Cleared Traditional

K791798 - CONPHAR SURGICAL RAZORR

K791798 · Conphar, Inc. · General & Plastic Surgery device
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Feb 1980
Decision
140d
Days
-
Risk

K791798 is an FDA 510(k) clearance for the CONPHAR SURGICAL RAZORR.

Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1980 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Conphar, Inc. devices

FDA 510(k) Submission Details - K791798

510(k) Number K791798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1979
Decision Date February 01, 1980
Days to Decision 140 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 23
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K791798.
PLASTIC DISPOSABLE RAZOR CAT.#1017,1018
K802003 · Pollak (Intl.), Ltd. · Sep 1980
AMPCO SKIN SCRUB TRAYS, CAT.#SS612
K802044 · Associated Medical Products Co. · Sep 1980
TUBE HOLDER
K801421 · Devon Industries, Inc. · Jul 1980
CUT-DOWN BUILT-UP TOILET SEAT
K772403 · Fred Sammons, Inc. · Feb 1978
ISOLATION KIT
K770381 · American Hospital Supply Corp. · Apr 1977
RAZOR, DISPOSABLE
K760328 · Devon Industries, Inc. · Aug 1976