Cleared Traditional

K813097 - ANAGO STERILE PRODUCTS

Also marketed or referenced as:
STOCKINETTES

K813097 is an FDA 510(k) clearance for ANAGO STERILE PRODUCTS, manufactured by Anago, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K813097 · Anago, Inc. · General Hospital
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Mar 1982
Decision
127d
Days
Class 2
Risk

K813097 is an FDA 510(k) clearance for the ANAGO STERILE PRODUCTS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Anago, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1982 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Anago, Inc. devices

FDA 510(k) Submission Details - K813097

510(k) Number K813097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1981
Decision Date March 10, 1982
Days to Decision 127 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 129d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 175
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K813097.
BARRIER ANTIMICROBIAL INCISE DRAPE
K820543 · Surgikos, Inc. · Jul 1982
SURGIKOS INCISE DRAPE
K820542 · Surgikos, Inc. · Jun 1982
CURITY PREMIUM CYSTOSCOPY TRAY
K820850 · The Kendal Co. · May 1982
STERILE ADHERENT DRAPES
K812809 · Abco Dealers, Inc. · Nov 1981
3M GERMICIDAL SURGICAL INCISE DRAPE
K801550 · 3M Company · Sep 1981
BACTERICIDAL INCISE DRAPE
K811871 · Surgikos, Inc. · Aug 1981