Cleared Traditional

K955586 - ROBISON & SMITH SURGICAL PACKS

K955586 is an FDA 510(k) clearance for ROBISON & SMITH SURGICAL PACKS, manufactured by Robison & Smith, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K955586 · Robison & Smith, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
267d
Days
Class 2
Risk

K955586 is an FDA 510(k) clearance for the ROBISON & SMITH SURGICAL PACKS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Robison & Smith, Inc. (Gloversville, US). The FDA issued a Cleared decision on August 30, 1996 after a review of 267 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Robison & Smith, Inc. devices

FDA 510(k) Submission Details - K955586

510(k) Number K955586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1995
Decision Date August 30, 1996
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 129d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 General Hospital devices follow this clearance model.

Regulatory Peers - FYA Gown, Surgical

All 166
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K955586.
PROVISION SURGICAL HELMET SYSTEM
K972832 · Depuy, Inc. · Oct 1997
CONVERTORS POLYOLEFIN FABRIC GOWNS
K961341 · Baxter Healthcare Corp · Oct 1996
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · Depuy, Inc. · Sep 1996
STRYKER STERI-SHIELD SURGICAL APPAREL
K944393 · Stryker Corp. · Aug 1995
COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS
K945371 · Standard Textile Co., Inc. · Apr 1995
PERVAL SURGICAL GOWN (MARKETING NAME)
K950504 · Standard Textile Co., Inc. · Apr 1995