Cleared Traditional

K893229 - SPATULA FOR PAP SMEAR COLLECTION

K893229 is an FDA 510(k) clearance for SPATULA FOR PAP SMEAR COLLECTION, manufactured by Medical Device Inspection Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K893229 · Medical Device Inspection Co., Inc. · Obstetrics & Gynecology device
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Feb 1990
Decision
300d
Days
Class 2
Risk

K893229 is an FDA 510(k) clearance for the SPATULA FOR PAP SMEAR COLLECTION. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on February 22, 1990 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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 Medical Device Inspection Co., Inc. devices

FDA 510(k) Submission Details - K893229

510(k) Number K893229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1989
Decision Date February 22, 1990
Days to Decision 300 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 160d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHT Device Classification - Class 2, Special Controls

Product Code HHT Spatula, Cervical, Cytological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - HHT Spatula, Cervical, Cytological

All 32
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K893229.
PURITAN FOAM TIP SWAB MODEL 2197
K961934 · Hardwood Products Co., LP · Jul 1996
DETECT CYTOLOGY BRUSH II
K960469 · Cook Urological, Inc. · Mar 1996
DETECT (TM) CYTOLOGY BRUSH
K933415 · Cook Ob/Gyn · Feb 1994
WALLACH CC/BRUSH
K896065 · Wallach Surgical Devices, Inc. · Jan 1990
KOTEX SUPER MAXI PADS
K890013 · Kimberly-Clark Corp. · Apr 1989
ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG
K891032 · Zinnanti Surgical Instruments, Inc. · Mar 1989