Cleared Traditional

K951577 - ES-3800

K951577 is the FDA 510(k) clearance for ES-3800 by Pentax Precision Instrument Corp.. It is a Class 2 Gastroenterology & Urology device (product code FAM) cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K951577 · Pentax Precision Instrument Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
352d
Days
Class 2
Risk

K951577 is an FDA 510(k) clearance for the ES-3800, VIDEO SIGMOIDOSCOPE. Classified as Sigmoidoscope And Accessories, Flexible/rigid (product code FAM), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Miramar, US). The FDA issued a Cleared decision on March 21, 1996 after a review of 352 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 Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K951577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1995
Decision Date March 21, 1996
Days to Decision 352 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 130d · This submission: 352d
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 19
Devices cleared under the same product code (FAM) and FDA review panel - the closest regulatory comparables to K951577.
VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100
K964100 · Vision-Sciences, Inc. · Dec 1996
DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
K963344 · Vision-Sciences, Inc. · Nov 1996
ES-3840, VIDEO SIGMOIDOSCOPE
K961567 · Pentax Precision Instrument Corp. · Jun 1996
VIDEO SIGMOIDOSCOPE
K950429 · Welch Allyn, Inc. · Aug 1995
FS-34P2, FIBER SIGMOIDOSCOPE
K951576 · Pentax Precision Instrument Corp. · Jun 1995
FS-38X, FIBER SIGMOIDOSCOPE
K951572 · Pentax Precision Instrument Corp. · Jun 1995