Cleared Traditional

K952569 - GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR

K952569 is an FDA 510(k) clearance for GAMP & ASSOCIATES THREE FUNCTION DISPOS..., manufactured by Gamp & Assoc.. The device is a Class 2 Ophthalmic device with product code HQR cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K952569 · Gamp & Assoc. · Ophthalmic device
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Jan 1996
Decision
214d
Days
Class 2
Risk

K952569 is an FDA 510(k) clearance for the GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR. Classified as Apparatus, Cautery, Radiofrequency, Ac-powered (product code HQR), Class II - Special Controls.

Submitted by Gamp & Assoc. (Bridgeton, US). The FDA issued a Cleared decision on January 5, 1996 after a review of 214 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4100 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Gamp & Assoc. devices

FDA 510(k) Submission Details - K952569

510(k) Number K952569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1995
Decision Date January 05, 1996
Days to Decision 214 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 110d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQR Device Classification - Class 2, Special Controls

Product Code HQR Apparatus, Cautery, Radiofrequency, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQR Apparatus, Cautery, Radiofrequency, Ac-powered

All 7
Devices cleared under the same product code (HQR) and FDA review panel - the closest regulatory comparables to K952569.
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