Cleared Traditional

K911787 - MONOPOLAR SPHINCTERTOME

K911787 is an FDA 510(k) clearance for MONOPOLAR SPHINCTERTOME, manufactured by Everest Medical Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K911787 · Everest Medical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
88d
Days
Class 2
Risk

K911787 is an FDA 510(k) clearance for the MONOPOLAR SPHINCTERTOME. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Everest Medical Corp. (Minneapolis, US). The FDA issued a Cleared decision on July 19, 1991 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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 Everest Medical Corp. devices

FDA 510(k) Submission Details - K911787

510(k) Number K911787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1991
Decision Date July 19, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1796
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K911787.
E-Z CLEAN LAPAROSCOPIC ELECTRODE
K913281 · Megadyne Medical Products, Inc. · Aug 1991
MODELS UES-10 & PSD-10
K911904 · Olympus Corp. · Jul 1991
ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE
K905752 · Beacon Laboratories, Inc. · Jul 1991
LAPAROSCOPIC ELECTRODE WITH LAVAGE AND SUCTION
K911476 · United States Endoscopy Group, Inc. · Jul 1991
LAPAROSCOPIC ELECTRODE
K911491 · United States Endoscopy Group, Inc. · Jul 1991
COOK TISSUE MORCELLATOR
K910939 · Cook Urological, Inc. · Jun 1991