Cleared Traditional

K884153 - CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE

K884153 is an FDA 510(k) clearance for CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE, manufactured by Candela Laser Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K884153 · Candela Laser Corp. · Gastroenterology & Urology device
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Dec 1988
Decision
89d
Days
Class 2
Risk

K884153 is an FDA 510(k) clearance for the CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Candela Laser Corp. (Wayland, US). The FDA issued a Cleared decision on December 28, 1988 after a review of 89 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 Candela Laser Corp. devices

FDA 510(k) Submission Details - K884153

510(k) Number K884153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1988
Decision Date December 28, 1988
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 131d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGB Device Classification - Class 2, Special Controls

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. 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 - FGB Ureteroscope And Accessories, Flexible/rigid

All 102
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K884153.
SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)
K904793 · Surgitek · Mar 1991
SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET
K902773 · Medical Engineering Corp. · Jul 1990
BARD SHORT RIGID URETEROSCOPE
K900813 · C.R. Bard, Inc. · May 1990
BARD URETEROSCOPIC DEVICE
K883110 · C.R. Bard, Inc. · Oct 1988
SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9
K880801 · Medical Engineering Corp. · May 1988
SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
K880802 · Medical Engineering Corp. · May 1988