Cleared Traditional

K982276 - BAHO AUTOCLAVABLE LAPAROSCOPE

K982276 is an FDA 510(k) clearance for BAHO AUTOCLAVABLE LAPAROSCOPE, manufactured by Microptix Int'L, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K982276 · Microptix Int'L, LLC · Obstetrics & Gynecology device
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Feb 1999
Decision
234d
Days
Class 2
Risk

K982276 is an FDA 510(k) clearance for the BAHO AUTOCLAVABLE LAPAROSCOPE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Microptix Int'L, LLC (East Haven, US). The FDA issued a Cleared decision on February 18, 1999 after a review of 234 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Microptix Int'L, LLC devices

FDA 510(k) Submission Details - K982276

510(k) Number K982276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1998
Decision Date February 18, 1999
Days to Decision 234 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 160d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 215
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K982276.
MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
K992480 · Medifix, Inc. · Sep 1999
LAP-WAVE 3000 (P07)
K990732 · W.O.M. World of Medicine GmbH · Jul 1999
DCI ENDOSCOPE
K990004 · KARL STORZ Endoscopy-America, Inc. · Apr 1999
POWER-DRIVE, WISAP MODEL #7688PD/7688PD1
K982515 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Jan 1999
AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
K982518 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Jan 1999
CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
K982428 · Innervision, Inc. · Oct 1998