Cleared Traditional

K903205 - AUTO SUTURE(R) ENDOSCOPIC CLAMP

K903205 is an FDA 510(k) clearance for AUTO SUTURE ENDOSCOPIC CLAMP, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 Obstetrics & Gynecology device with product code HDA cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K903205 · United States Surgical, A Division of Tyco Healthc · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
83d
Days
Class 2
Risk

K903205 is an FDA 510(k) clearance for the AUTO SUTURE(R) ENDOSCOPIC CLAMP. Classified as Forceps, Obstetrical (product code HDA), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on October 11, 1990 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K903205

510(k) Number K903205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1990
Decision Date October 11, 1990
Days to Decision 83 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
77d faster than avg
Panel avg: 160d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDA Device Classification - Class 2, Special Controls

Product Code HDA Forceps, Obstetrical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4400
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 - HDA Forceps, Obstetrical

Devices cleared under the same product code (HDA) and FDA review panel - the closest regulatory comparables to K903205.
INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
K100517 · Instrumed International, Inc. · Apr 2010
DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
K092827 · Dimeda Instrumente GmbH · Jan 2010
V. MUELLER OBSTETRICAL (OB) FORCEPS
K951529 · Baxter Healthcare Corp · Aug 1995
MIDWIFERY/OBSTETRICAL FORCEPS
K890385 · Kinetic Medical Products · Mar 1989
SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420
K851883 · The Huxley Instrument Corp. · May 1985