Cleared Traditional

K770539 - FORCEPS, HAEM, DEEP OPERATION, 20&22 CM.

K770539 is an FDA 510(k) clearance for FORCEPS, manufactured by Sea-Pac Trading Corp.. The device is a Class 1 General & Plastic Surgery device with product code GEN cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K770539 · Sea-Pac Trading Corp. · General & Plastic Surgery device
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Apr 1977
Decision
25d
Days
Class 1
Risk

K770539 is an FDA 510(k) clearance for the FORCEPS, HAEM, DEEP OPERATION, 20&22 CM.. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Sea-Pac Trading Corp. (Mchenry, US). The FDA issued a Cleared decision on April 15, 1977 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: 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 Sea-Pac Trading Corp. devices

FDA 510(k) Submission Details - K770539

510(k) Number K770539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1977
Decision Date April 15, 1977
Days to Decision 25 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

GEN Device Classification - Class 1, General Controls

Product Code GEN Forceps, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GEN Forceps, General & Plastic Surgery

All 69
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K770539.
SUTURE TISSUE APPROXIMATING FORCEP
K771515 · United States Surgical, A Division of Tyco Healthc · Sep 1977
FORCEPS
K771746 · Depuy, Inc. · Sep 1977
ANGLED FORCEP APPLIER
K771691 · Edward Weck, Inc. · Sep 1977
WOMB PREP KIT
K770329 · American Hospital Supply Corp. · Apr 1977
MARCUSE TUBE CLAMPING FORCEPS, STRAIGHT
K761334 · J. Sklar Mfg. Co., Inc. · Feb 1977
FORCEP, THUMB
K760507 · Acme United Corp. · Nov 1976