Cleared Traditional

AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV (K910921) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910921 · United States Surgical, A Division of Tyco Healthc · Obstetrics & Gynecology device
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Aug 1991
Decision
174d
Days
Class 2
Risk

K910921 is an FDA 510(k) clearance for the AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on August 26, 1991 after a review of 174 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K910921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1991
Decision Date August 26, 1991
Days to Decision 174 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
14d slower than avg
Panel avg: 160d · This submission: 174d
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 92
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K910921.
CONDUCTIVE SURGIGRIP SPIRAL SLEEVE
K915338 · United States Surgical, A Division of Tyco Healthc · Sep 1992
DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR
K914968 · Ethicon, Inc. · Feb 1992
ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF
K912398 · Ethicon, Inc. · Dec 1991
ENDOTHRED ADJUSTABLE STABILITLY THEREAD
K910008 · Ethicon, Inc. · Mar 1991
LAPAROSCOPE
K905196 · Baxter Healthcare Corp · Mar 1991
AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE
K905426 · United States Surgical, A Division of Tyco Healthc · Feb 1991