Cleared Traditional

K933698 - 100 SERIES ENDOSCOPIC GRASPING FORCEPS

K933698 is the FDA 510(k) clearance for 100 SERIES ENDOSCOPIC GRASPING FORCEPS by Cook Urological, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K933698 · Cook Urological, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
231d
Days
Class 2
Risk

K933698 is an FDA 510(k) clearance for the 100 SERIES ENDOSCOPIC GRASPING FORCEPS. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on March 17, 1994 after a review of 231 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 Cook Urological, Inc. devices

Submission Details

510(k) Number K933698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date March 17, 1994
Days to Decision 231 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 160d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 131
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K933698.
ENDOSCOPE
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TROGARD TROCAR SLEEVE RETAINING THREAD
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K934451 · Cook Urological, Inc. · Mar 1994
FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE
K915857 · Olympus Corp. · Mar 1994
ENDOPATH RELOADABLE LINEAR CUTTER
K930934 · Ethicon, Inc. · Mar 1994