Cleared Traditional

K822765 - SIGMOIDOSCOPE

K822765 is the FDA 510(k) clearance for SIGMOIDOSCOPE by Harvard Laboratories. It is a Class 2 Gastroenterology & Urology device (product code FAM) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K822765 · Harvard Laboratories · Gastroenterology & Urology device
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Nov 1982
Decision
64d
Days
Class 2
Risk

K822765 is an FDA 510(k) clearance for the SIGMOIDOSCOPE, FLEXIBLE. Classified as Sigmoidoscope And Accessories, Flexible/rigid (product code FAM), Class II - Special Controls.

Submitted by Harvard Laboratories (Walker, US). The FDA issued a Cleared decision on November 17, 1982 after a review of 64 days - a notably fast clearance cycle.

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: 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 Harvard Laboratories devices

Submission Details

510(k) Number K822765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1982
Decision Date November 17, 1982
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAM Sigmoidoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Sigmoid (descending) Colon
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 - FAM Sigmoidoscope And Accessories, Flexible/rigid

All 10
Devices cleared under the same product code (FAM) and FDA review panel - the closest regulatory comparables to K822765.
FS-34P2, FIBER SIGMOIDOSCOPE
K951576 · Pentax Precision Instrument Corp. · Jun 1995
FS-38X, FIBER SIGMOIDOSCOPE
K951572 · Pentax Precision Instrument Corp. · Jun 1995
FS-38H, FIBER SIGMOIDOSCOPE
K951573 · Pentax Precision Instrument Corp. · Jun 1995
PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34
K792341 · Pentax Precision Instrument Corp. · Dec 1979
SIGMOIDOSCOPE TIPLESS
K790610 · Welch Allyn, Inc. · Apr 1979
SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125
K770291 · Welch Allyn, Inc. · Feb 1977