Cleared Traditional

K933770 - FORCEPS

K933770 is an FDA 510(k) clearance for FORCEPS, manufactured by Mahe-Medizintechnik. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K933770 · Mahe-Medizintechnik · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
237d
Days
Class 1
Risk

K933770 is an FDA 510(k) clearance for the FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Mahe-Medizintechnik (Nashville, US). The FDA issued a Cleared decision on March 23, 1994 after a review of 237 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Mahe-Medizintechnik devices

FDA 510(k) Submission Details - K933770

510(k) Number K933770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date March 23, 1994
Days to Decision 237 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 89d · This submission: 237d
Pathway characteristics
Predicate-based equivalence.

LRC Device Classification - Class 1, General Controls

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LRC Instrument, Ent Manual Surgical

All 55
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K933770.
DISPOSABLE NASAL SCISSOR
K942063 · United States Surgical, A Division of Tyco Healthc · Jun 1994
DISPOSABLE NASAL RONGEUR
K942064 · United States Surgical, A Division of Tyco Healthc · Jun 1994
DISPOSABLE ENT PUNCH
K942065 · United States Surgical, A Division of Tyco Healthc · Jun 1994
SYMBIOSIS ENT SURGICAL INSTRUMENTS
K931793 · Symbiosis Corp. · Jul 1993
HOUSE-BELLUCCI ALLIGATOR SCISSORS
K930292 · Thomasville Medical Assoc. · Mar 1993
ATMOS MIRROR WARMER
K920988 · Jedmed Instrument Co. · May 1992