Cleared Traditional

K930032 - RETRACTOR RODS

K930032 is an FDA 510(k) clearance for RETRACTOR RODS, manufactured by Thomasville Medical Assoc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNA cleared through the Traditional 510(k) pathway after a 401-day FDA review.

K930032 · Thomasville Medical Assoc. · Obstetrics & Gynecology device
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Feb 1994
Decision
401d
Days
Class 2
Risk

K930032 is an FDA 510(k) clearance for the RETRACTOR RODS. Classified as Instrument, Manual, Specialized Obstetric-gynecologic (product code KNA), Class II - Special Controls.

Submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on February 10, 1994 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Thomasville Medical Assoc. devices

FDA 510(k) Submission Details - K930032

510(k) Number K930032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1993
Decision Date February 10, 1994
Days to Decision 401 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
241d slower than avg
Panel avg: 160d · This submission: 401d
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 30
Devices cleared under the same product code (KNA) and FDA review panel - the closest regulatory comparables to K930032.
MICRO SURGERY SCISSORS
K930031 · Thomasville Medical Assoc. · Feb 1994
MICRO SURGERY NEEDLE HOLDERS
K930110 · Thomasville Medical Assoc. · Feb 1994
VARIOUS SCISSORS
K930727 · Thomasville Medical Assoc. · Feb 1994
C-SECTION TRAY
K912075 · Medical Device Inspection Co., Inc. · Apr 1992
RETRACTOR RODS
K891398 · Zinnanti Surgical Instruments, Inc. · May 1989
GREENE-ARMYTAGE HEMOSTATIC FORCEPS
K891397 · Zinnanti Surgical Instruments, Inc. · Mar 1989