Cleared Traditional

K863089 - DISPOSABLE LASER SPONGE SURGIMEDICS

K863089 is an FDA 510(k) clearance for DISPOSABLE LASER SPONGE SURGIMEDICS, manufactured by Lifestream Int'L, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K863089 · Lifestream Int'L, Inc. · General & Plastic Surgery device
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Oct 1986
Decision
62d
Days
Class 1
Risk

K863089 is an FDA 510(k) clearance for the DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Lifestream Int'L, Inc. (Sugar Land, US). The FDA issued a Cleared decision on October 14, 1986 after a review of 62 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4450 - 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 Lifestream Int'L, Inc. devices

FDA 510(k) Submission Details - K863089

510(k) Number K863089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1986
Decision Date October 14, 1986
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

GDY Device Classification - Class 1, General Controls

Product Code GDY Gauze/sponge, Internal, X-ray Detectable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4450
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 - GDY Gauze/sponge, Internal, X-ray Detectable

All 23
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K863089.
ICAN K DISSECTOR SPONGES
K914083 · Icn Pharmaceuticals, Inc. · Oct 1991
ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
K903358 · Advance Medical Designs, Inc. · Nov 1990
QUALTEX NEUROLOK SURGICAL SPONGE
K884790 · Deroyal Industries, Inc. · Dec 1988
POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
K830201 · American Medical Disposable, Inc. · Feb 1983
COTTON BALLS, X-RAY OPAQUED STRUNG & NON
K830202 · American Medical Disposable, Inc. · Feb 1983
X-RAY DETECTABLE LAP SPONGES
K812651 · Procter & Gamble Mfg. Co. · Oct 1981