Cleared Traditional

K910008 - ENDOTHRED ADJUSTABLE STABILITLY THEREAD

K910008 is the FDA 510(k) clearance for ENDOTHRED ADJUSTABLE STABILITLY THEREAD by Ethicon, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K910008 · Ethicon, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
78d
Days
Class 2
Risk

K910008 is an FDA 510(k) clearance for the ENDOTHRED ADJUSTABLE STABILITLY THEREAD. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on March 21, 1991 after a review of 78 days - a notably fast clearance 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: 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 Ethicon, Inc. devices

Submission Details

510(k) Number K910008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1991
Decision Date March 21, 1991
Days to Decision 78 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
82d faster than avg
Panel avg: 160d · This submission: 78d
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 150
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K910008.
AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV
K910921 · United States Surgical, A Division of Tyco Healthc · Aug 1991
TROCAR ACCESS SHEATH
K905471 · Cook Ob/Gyn · May 1991
PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE
K904848 · Origin Medsystems, Inc. · Apr 1991
LAPAROSCOPE
K905196 · Baxter Healthcare Corp · Mar 1991
LAPAROSCOPIC ASPIRATION PROBE
K910340 · Davol, Inc. · Feb 1991
AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE
K905426 · United States Surgical, A Division of Tyco Healthc · Feb 1991