Cleared Traditional

K971277 - SAFE-T-CLAMP

K971277 is an FDA 510(k) clearance for SAFE-T-CLAMP, manufactured by Talon Medical, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code KNA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K971277 · Talon Medical, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
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May 1997
Decision
43d
Days
Class 2
Risk

K971277 is an FDA 510(k) clearance for the SAFE-T-CLAMP. Classified as Instrument, Manual, Specialized Obstetric-gynecologic (product code KNA), Class II - Special Controls.

Submitted by Talon Medical, Ltd. (San Antonio, US). The FDA issued a Cleared decision on May 20, 1997 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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 Talon Medical, Ltd. devices

FDA 510(k) Submission Details - K971277

510(k) Number K971277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1997
Decision Date May 20, 1997
Days to Decision 43 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 160d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNA Device Classification - Class 2, Special Controls

Product Code KNA Instrument, Manual, Specialized Obstetric-gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - KNA Instrument, Manual, Specialized Obstetric-gynecologic

All 35
Devices cleared under the same product code (KNA) and FDA review panel - the closest regulatory comparables to K971277.
UROMED SLING KIT
K980717 · Uromed Corp. · May 1998
GYNEX ENDOSPECULUM
K980237 · Gynex Corp. · Apr 1998
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS
K972013 · National Healthcare Mfg. Corp. · Aug 1997
BALLOON UTERINE STENT
K952527 · Cook Urological, Inc. · Jan 1996
CORDGUARD II
K954619 · Utah Medical Products, Inc. · Dec 1995
ENDO CERVICAL CURETTE
K926532 · Thomasville Medical Assoc. · Feb 1994