Cleared Traditional

K961563 - EC-384OTL

K961563 is an FDA 510(k) clearance for EC-384OTL, manufactured by Pentax Precision Instrument Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K961563 · Pentax Precision Instrument Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
57d
Days
Class 2
Risk

K961563 is an FDA 510(k) clearance for the EC-384OTL, VIDEO COLONSCOPE. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Orangeburg, US). The FDA issued a Cleared decision on June 19, 1996 after a review of 57 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 Pentax Precision Instrument Corp. devices

FDA 510(k) Submission Details - K961563

510(k) Number K961563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1996
Decision Date June 19, 1996
Days to Decision 57 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
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDF Device Classification - Class 2, Special Controls

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FDF Colonoscope And Accessories, Flexible/rigid

All 72
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K961563.
GF-UE160-AL5 ULTRASOUND ENDOSCOPE
K051541 · Olympus America, Inc. · Jul 2005
FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
K041903 · Fujinon, Inc. · Nov 2004
KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)
K961570 · Pentax Precision Instrument Corp. · Jun 1996
EC-3800L, VIDEO COLONOSCOPE
K951574 · Pentax Precision Instrument Corp. · Mar 1996
EC-3800TL, VIDEO COLONOSCOPE
K951579 · Pentax Precision Instrument Corp. · Mar 1996
VS-200 VIDEO SIGMOIDOSCOPE
K954704 · Welch Allyn, Inc. · Mar 1996