Cleared Traditional

K932634 - NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/...

K932634 is the FDA 510(k) clearance for NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/... by Marlo Surgical Technology. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K932634 · Marlo Surgical Technology · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Feb 1994
Decision
268d
Days
Class 2
Risk

K932634 is an FDA 510(k) clearance for the NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Marlo Surgical Technology (Willoughby, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 268 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 Marlo Surgical Technology devices

Submission Details

510(k) Number K932634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1993
Decision Date February 25, 1994
Days to Decision 268 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 160d · This submission: 268d
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 151
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K932634.
FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE
K915857 · Olympus Corp. · Mar 1994
ENDOPATH RELOADABLE LINEAR CUTTER
K930934 · Ethicon, Inc. · Mar 1994
RETRACTORS AND SCRAPER
K933008 · Baxter Healthcare Corp · Mar 1994
TROCAR STABILITY THREAD
K923568 · Applied Medical Resources · Dec 1993
TROCAR W/ BLUNT TIP OBTURATOR
K923636 · Applied Medical Resources · Nov 1993
URESIL LAPAROSCOPIC RETRACTOR
K921417 · Uresil Corp. · Oct 1993