Cleared Traditional

PUTMAN STABILIZER (K915317) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915317 · J. Michael Putman, M.D., P.A. · General & Plastic Surgery device
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Nov 1992
Decision
350d
Days
Class 2
Risk

K915317 is an FDA 510(k) clearance for the PUTMAN STABILIZER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by J. Michael Putman, M.D., P.A. (Dallas, US). The FDA issued a Cleared decision on November 6, 1992 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all J. Michael Putman, M.D., P.A. devices

Submission Details

510(k) Number K915317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1991
Decision Date November 06, 1992
Days to Decision 350 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
235d slower than avg
Panel avg: 115d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 399
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K915317.
AESCULAP TROCAR INSTRUMENT SET
K922797 · Aesculap, Inc. · Mar 1993
OLYMPUS OES LAPAROSCOPY SYSTEM
K923982 · Olympus Corp. · Mar 1993
AUTO SUTURE ENDOSCOPIC KNOT PUSHER
K925149 · United States Surgical, A Division of Tyco Healthc · Jan 1993
AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR
K920068 · United States Surgical, A Division of Tyco Healthc · Sep 1992
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS
K914752 · United States Surgical, A Division of Tyco Healthc · Jun 1992
LAP TISSUE COLLECTION BAG
K915286 · Baxter Healthcare Corp · Apr 1992