Cleared Traditional

K962212 - KARL STORZ FRIMBERGER VARIOGUIDE

K962212 is an FDA 510(k) clearance for KARL STORZ FRIMBERGER VARIOGUIDE, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDT cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K962212 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
186d
Days
Class 2
Risk

K962212 is an FDA 510(k) clearance for the KARL STORZ FRIMBERGER VARIOGUIDE. Classified as Duodenoscope And Accessories, Flexible/rigid (product code FDT), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on December 13, 1996 after a review of 186 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K962212

510(k) Number K962212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1996
Decision Date December 13, 1996
Days to Decision 186 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
55d slower than avg
Panel avg: 131d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDT Device Classification - Class 2, Special Controls

Product Code FDT Duodenoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine The Duodenum And To Perform Various Procedures Within The Duodenum. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type 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 - FDT Duodenoscope And Accessories, Flexible/rigid

All 33
Devices cleared under the same product code (FDT) and FDA review panel - the closest regulatory comparables to K962212.
FUJINON G5 DUODENSCOPES
K042076 · Fujinon, Inc. · Nov 2004
XTJF-160AF DUODENOVIDEOSCOPE
K024033 · Olympus Optical Co., Ltd. · Dec 2002
OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
K980465 · Olympus America, Inc. · Apr 1998
ED-3410, VIDEO DUODENOSCOPE
K963056 · Pentax Precision Instrument Corp. · Oct 1996
ED-344OT
K961568 · Pentax Precision Instrument Corp. · Jul 1996
OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES
K942338 · Olympus Corp. · Nov 1994