Atlas FDA

URETERAL DILATOR

FDA 510(k) clearance K840746 · decided 1984-04-13

Clearance details

K-number
K840746
Device name
URETERAL DILATOR
Applicant
American Edwards Laboratories
Decision
Substantially Equivalent
Date received
1984-01-19
Decision date
1984-04-13
Days to decision
85 days
Clearance type
Traditional
Product code
KOE
Device class
2
Regulation number
876.5520
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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U.S. MEDICAL PS-7000 DIALYSIS SCALE (K924440)U.S. Medical Corp.1993-05-26
120 FR OPTILUME PROSTATE BALLOON DILATOR (K920551)American Medical Systems, Inc.1992-10-28
DOWD(TM) II (K922349)Boston Scientific Corp1992-08-14
ENTRAC URETHRAL BALLOON DILATATION CATHETER (K920711)American Medical Systems, Inc.1992-05-06
APEX(TM) PROSTATIC BALLOON DILATION CATHETER (K913477)Peripheral Systems Group1991-12-27
UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER (K902585)Advanced Surgical Intervention, Inc.1990-08-27
ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. (K896713)Advanced Surgical Intervention, Inc.1990-05-24

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
GARREN GASTRIC BUBBLE (P840025/S011)American Edwards Laboratories1987-03-17
GARREN GASTRIC BUBBLE (P840025/S008)American Edwards Laboratories1986-10-16
GARREN GASTRIC BUBBLE (P840025/S006)American Edwards Laboratories1986-07-25
GARREN{TM}-EDWARDS GASTRIC BUBBLE (P840025/S005)American Edwards Laboratories1986-05-12
GARREN GASTRIC BUBBLE (P840025/S003)American Edwards Laboratories1986-01-23
GARREN GASTRIC BUBBLE (P840025/S002)American Edwards Laboratories1986-01-23
GARREN GASTRIC BUBBLE (P840025/S004)American Edwards Laboratories1986-01-23
GARREN GASTRIC BUBBLE (P840025/S001)American Edwards Laboratories1985-12-18