Cleared Traditional

THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE (K121135) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121135 · Thd Spa · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 2012
Decision
49d
Days
Class 2
Risk

K121135 is an FDA 510(k) clearance for the THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Thd Spa (Imoa, IT). The FDA issued a Cleared decision on June 1, 2012 after a review of 49 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 Thd Spa devices

Submission Details

510(k) Number K121135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2012
Decision Date June 01, 2012
Days to Decision 49 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 130d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FER Anoscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Anus And Rectum.
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 - FER Anoscope And Accessories

All 8
Devices cleared under the same product code (FER) and FDA review panel - the closest regulatory comparables to K121135.
Gastro Concepts Air Assist
K242668 · Gastro Concepts, LLC · Dec 2024
WellCare Anoscope
K230439 · Well Care (Wuhan) Medical Technology Co., Ltd. · Dec 2023
Applied Medical Anoscope
K200021 · Applied Medical Resources · Jan 2021
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K093896 · Ethicon Endo-Surgery, Inc. · Mar 2010
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
K881469 · Baxter Healthcare Corp · Sep 1988
MODEL #53110 DISPOSABLE ANOSCOPE
K810227 · Welch Allyn, Inc. · Feb 1981