Cleared Traditional

K861141 - MANUAL OPHTHALMIC SURGICAL INSTRUMENTS

K861141 is an FDA 510(k) clearance for MANUAL OPHTHALMIC SURGICAL INSTRUMENTS, manufactured by CooperVision, Inc.. The device is a Class 1 Ophthalmic device with product code HNR cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K861141 · CooperVision, Inc. · Ophthalmic device
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Apr 1986
Decision
29d
Days
Class 1
Risk

K861141 is an FDA 510(k) clearance for the MANUAL OPHTHALMIC SURGICAL INSTRUMENTS. Classified as Forceps, Ophthalmic (product code HNR), Class I - General Controls.

Submitted by CooperVision, Inc. (Bellevue, US). The FDA issued a Cleared decision on April 24, 1986 after a review of 29 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 CooperVision, Inc. devices

FDA 510(k) Submission Details - K861141

510(k) Number K861141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1986
Decision Date April 24, 1986
Days to Decision 29 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
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

HNR Device Classification - Class 1, General Controls

Product Code HNR Forceps, 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 - HNR Forceps, Ophthalmic

All 32
Devices cleared under the same product code (HNR) and FDA review panel - the closest regulatory comparables to K861141.
THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND
K863991 · Keeler Instruments, Inc. · Oct 1986
THORNTON TITANIUM FORCEPS (VARIOUS TYPES)
K863992 · Keeler Instruments, Inc. · Oct 1986
PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS
K864003 · Allergan, Inc. · Oct 1986
STORZ/MAZZACCO LENS FORCEP
K860915 · Storz Instrument Co. · Apr 1986
INTRAOCULAR FORCEPS & SCISSORS
K854869 · Mira, Inc. · Mar 1986
37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS
K851791 · Artiberia · May 1985