Atlas FDA

BROWNE MODEL GD-5

FDA 510(k) clearance K792093 · decided 1979-12-06

Clearance details

K-number
K792093
Device name
BROWNE MODEL GD-5
Applicant
Browne Corp.
Decision
Substantially Equivalent
Date received
1979-10-17
Decision date
1979-12-06
Days to decision
50 days
Clearance type
Traditional
Product code
FAP
Device class
2
Regulation number
876.1620
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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RecordFirmDate
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SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE (K974775)Airtronic Services, Inc.1998-02-19
URODYNAMIC ANALYSIS MODULE (K963330)Synectics Medical, Inc.1997-04-03
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER (K962472)Rusch Intl.1996-08-27
SCHUSTER DISPOSABLE BALLOON PROBE (K931175)Sandhill Scientific, Inc.1994-04-01
UROLAB SPECTRUM (K931179)Life-Tech Intl., Inc.1993-11-18
URO-PRO 2000 (K922476)Fiberoptic Sensor Technlogies, Inc.1993-07-20
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (K924383)Synectics-Dantec1993-06-18
URODYNAMICS TUBING KITS #5161, #5150, #7170 (K923995)Advanced Medical Products, Inc.1993-04-08
URODYNAMIC CATHETERS (K923464)R.L. Medical Corp.1993-02-05
NICKI, MODEL NUMBER USD-NK-UP1 (K924086)Laborie Medical Technologies, Ltd.1992-10-20
ENDOTEK ULTRA SYSTEM (K920451)Surgitek1992-09-17

Recalls involving this device

No recalls on record reference this clearance.