Cleared Traditional

K760847 - FELDSTEIN BLEPHAROPLASTY CLIP SHARP P

K760847 is the FDA 510(k) clearance for FELDSTEIN BLEPHAROPLASTY CLIP SHARP P by V. Mueller O.V. Baxter Healthcare Corp.. It is a Class 1 Ophthalmic device (product code HNC) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K760847 · V. Mueller O.V. Baxter Healthcare Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1976
Decision
18d
Days
Class 1
Risk

K760847 is an FDA 510(k) clearance for the FELDSTEIN BLEPHAROPLASTY CLIP SHARP P. Classified as Specula, Ophthalmic (product code HNC), Class I - General Controls.

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1976 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic 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 V. Mueller O.V. Baxter Healthcare Corp. devices

Submission Details

510(k) Number K760847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1976
Decision Date November 02, 1976
Days to Decision 18 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 110d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNC Specula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
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 - HNC Specula, Ophthalmic

Devices cleared under the same product code (HNC) and FDA review panel - the closest regulatory comparables to K760847.
THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
K863989 · Keeler Instruments, Inc. · Oct 1986
VISITEC EYE SPECULUM
K843196 · Visitec Co. · Oct 1984
ASNIS GUIDED SCREW SYSTEMS
K801969 · Howmedica Corp. · Aug 1980
FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU
K760848 · V. Mueller O.V. Baxter Healthcare Corp. · Nov 1976
FELDSTEIN BLEPHAROSTOMY CLIP SQUARE
K760849 · V. Mueller O.V. Baxter Healthcare Corp. · Nov 1976