Atlas FDA

SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM

FDA 510(k) clearance K972979 · decided 1997-12-11

Clearance details

K-number
K972979
Device name
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
1997-08-11
Decision date
1997-12-11
Days to decision
122 days
Clearance type
Traditional
Product code
FBO
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Andover, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) (K244001)Karl Storz SE & CO. KG2025-05-02
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) (K243409)Karl Storz SE & CO. KG2024-11-27
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE (K131364)KARL STORZ Endoscopy-America, Inc.2014-01-02
KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO (K082046)KARL STORZ Endoscopy-America, Inc.2008-10-10
ANCHORAGE SCOPE, MODEL 000003 (K080780)Epitek, Inc.2008-07-30
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM (K062918)KARL STORZ Endoscopy-America, Inc.2007-01-17
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES (K061646)Laserscope2006-06-27
CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 (K011496)Richard Wolf Medical Instruments Corp.2001-08-10
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) (K962474)Olympus America, Inc.1996-12-20
CYSTOSCOPE (K941992)Surgical Technologies, Inc.1995-11-30
CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS (K951972)Cabot Medical Corp.1995-07-21
CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) (K945185)KARL STORZ Endoscopy-America, Inc.1995-05-03

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Ascension MCP (P000057/S013)Smith & Nephew, Inc.2025-12-31
ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
R3™ Delta Ceramic Acetabular System (P150030/S049)Smith & Nephew, Inc.2025-04-17
R3 DELTA CERAMIC HIP SYSTEM (P150030/S048)Smith & Nephew, Inc.2025-03-03
R3 Delta Ceramic Hip System (P150030/S045)Smith & Nephew, Inc.2025-02-28
R3™ Delta Ceramic Acetabular System (P150030/S047)Smith & Nephew, Inc.2025-02-21
R3™ Delta Ceramic Acetabular System (P150030/S046)Smith & Nephew, Inc.2025-01-16
BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10