Cleared Traditional

K833730 - NON ADHERENT BANDAGE/SHEET

K833730 · American Medical Disposable, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1984
Decision
94d
Days
-
Risk

K833730 is an FDA 510(k) clearance for the NON ADHERENT BANDAGE/SHEET. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by American Medical Disposable, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 94 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Medical Disposable, Inc. devices

FDA 510(k) Submission Details - K833730

510(k) Number K833730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1983
Decision Date January 27, 1984
Days to Decision 94 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 115d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 490
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K833730.
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K841287 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984
HYDRON WOUND DRESSING FAST SEAT KIT
K832699 · National Patent Development Corp. · Apr 1984
STERILE ABSORBENT GAUZE BURN & SOUND
K840745 · Chesebrough-Pond'S U.S.A. Co. · Apr 1984
DECUBITUS CARE ABSORBENT DRESSING
K832407 · American Pharmaseal Div. Ahsc · Jan 1984
BARD ABSORPTION DRESSING
K831710 · C.R. Bard, Inc. · Jan 1984
NON - ADHERENT BANDAGE
K833733 · American Medical Disposable, Inc. · Dec 1983