Cleared Traditional

K921291 - INMAN MEDICAL PACKING STRIP

K921291 is an FDA 510(k) clearance for INMAN MEDICAL PACKING STRIP, manufactured by Inman Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FER cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K921291 · Inman Medical Corp. · Gastroenterology & Urology device
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Jan 1993
Decision
316d
Days
Class 2
Risk

K921291 is an FDA 510(k) clearance for the INMAN MEDICAL PACKING STRIP. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Inman Medical Corp. (Fort Worth, US). The FDA issued a Cleared decision on January 21, 1993 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inman Medical Corp. devices

FDA 510(k) Submission Details - K921291

510(k) Number K921291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1992
Decision Date January 21, 1993
Days to Decision 316 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 130d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FER Device Classification - Class 2, Special Controls

Product Code FER Anoscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Anus And Rectum.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FER Anoscope And Accessories

All 12
Devices cleared under the same product code (FER) and FDA review panel - the closest regulatory comparables to K921291.
GELPOINT PATH
K110792 · Applied Medical Resources Corp. · May 2011
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K093896 · Ethicon Endo-Surgery, Inc. · Mar 2010
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
K060623 · Cook Ireland, Ltd. · Sep 2006
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
K881469 · Baxter Healthcare Corp · Sep 1988
MODEL #53110 DISPOSABLE ANOSCOPE
K810227 · Welch Allyn, Inc. · Feb 1981
ANOSCOPE, OPTIC, FIBER
K770906 · Welch Allyn, Inc. · Jun 1977