FDA Review Panel · OB

FDA 510(k) Obstetrics & Gynecology Devices

FDA 510(k) Obstetrics & Gynecology Devices - Regulatory Overview

FDA 510(k) obstetrics and gynecology (OB/GYN) devices include diagnostic and therapeutic equipment for women's reproductive health. The FDA review panel code is OB.

Key categories:

Fetal monitoring systems - CTG monitors, fetal dopplers, scalp electrodes
Intrauterine devices (IUDs) - hormonal and copper contraceptive devices
Breast pumps and lactation aids - electric and manual breast pumps
Gynecological surgical instruments - hysteroscopes, laparoscopic tools, ablation systems
Pregnancy test systems - hCG detection devices for professional and home use

4525

Total

4511

Cleared

167d

Avg (2y)

1976

Since

4525 Obstetrics & Gynecology devices

2226–2250 of 4525

Cleared Jul 21, 1999

K984392 · Ansell, Inc.

HIS · Condom · 225d

Cleared Jul 19, 1999

SUMMER'S EVE LUBRICATING JELLY

K990597 · C.B. Fleet Co., Inc.

HIS · Condom · 145d

Cleared Jul 19, 1999

K991104 · Conception Technology, Inc.

MQH · Microtools, Assisted Reproduction (pipettes) · 109d

Cleared Jul 19, 1999

FERTILIZATION MEDIA-HTF

K991173 · Intl., Inc.

MQL · Media, Reproductive · 103d

Cleared Jul 19, 1999

FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR

K991408 · Thermoquest Corp.

MQG · Accessory, Assisted Reproduction · 88d

Cleared Jul 19, 1999

SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES

K991700 · Swemed Lab International AB

MQH · Microtools, Assisted Reproduction (pipettes) · 62d

Cleared Jul 19, 1999

GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043

K991827 · Ri Mos. S.R.L.

HIB · Speculum, Vaginal, Nonmetal · 52d

Cleared Jul 14, 1999

INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M

K990847 · Humagen Fertility Diagnostics, Inc.

MQH · Microtools, Assisted Reproduction (pipettes) · 121d

Cleared Jul 14, 1999

NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L

K990941 · Humagen Fertility Diagnostics, Inc.

MQK · Labware, Assisted Reproduction · 114d

Cleared Jul 14, 1999

BOVINE SERUM ALBUMIN (BSA)

K991338 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 86d

Cleared Jul 14, 1999

PVP (POLYVINYLPYRROLIDONE)

K991343 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 86d

Cleared Jul 08, 1999

SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)

K991235 · Ludlow Technical Products

KXO · Monitor, Pressure, Intrauterine · 87d

Cleared Jul 08, 1999

K991263 · Tokai Hit Co., Ltd.

MQG · Accessory, Assisted Reproduction · 86d

Cleared Jul 08, 1999

SPERM MAINTENANCE MEDIUM WITH GLYCEROL

K991337 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 80d

Cleared Jul 08, 1999

ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION

K991341 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 80d

Cleared Jul 08, 1999

PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION

K991342 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 80d

Cleared Jul 06, 1999

LIFESTYLES XTRA PLEASURE

K983518 · Ansell, Inc.

HIS · Condom · 272d

Cleared Jul 02, 1999

MODIFIED HAM'S F-10 WITH ALBUMIN

K991420 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 70d

Cleared Jul 02, 1999

FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB)

K991421 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 70d

Cleared Jun 29, 1999

O.B. APPLICATOR TAMPONS, O.B. TAMPONS

K991118 · Personal Products Co.

HEB · Tampon, Menstrual, Unscented · 89d

Cleared Jun 29, 1999

K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L

K991229 · Henning Knudsen Engineering A/S

MQG · Accessory, Assisted Reproduction · 78d

Cleared Jun 29, 1999

ORIBRUSH - STANDARD - B002

K991593 · Orifice Medical AB

HHT · Spatula, Cervical, Cytological · 53d

Cleared Jun 29, 1999

ORIBRUSH - WITH PROTECTIVE TIP - B001

K991595 · Orifice Medical AB

HHT · Spatula, Cervical, Cytological · 53d

Cleared Jun 18, 1999

HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)

K991047 · Hardcover Products, Inc.

LTZ · Condom With Nonoxynol-9 · 80d

Cleared Jun 17, 1999

MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)

K990925 · Hardcover Products, Inc.

HIS · Condom · 90d

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