Atlas FDA

CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS

FDA 510(k) clearance K943327 · decided 1994-11-07

Clearance details

K-number
K943327
Device name
CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS
Applicant
Conmedcorp
Decision
Substantially Equivalent
Date received
1994-07-12
Decision date
1994-11-07
Days to decision
118 days
Clearance type
Traditional
Product code
GCJ
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Utica, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ConMed Laparoscopic Instrument: Allis Disposable Grasper, 5mm x 33cm length, REF/Product C recall (Z-0093-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Allis Disposable Grasper, 5mm x 43cm length, REF/Product C recall (Z-0094-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 33cm length, REF/Product recall (Z-0095-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length, REF/Product recall (Z-0096-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Grasper, 5mm x 33cm length, recall (Z-0097-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Grasper, 5mm x 43cm length, recall (Z-0098-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Endoweave Disposable Grasper, 5mm x 33cm length, REF/Produ recall (Z-0099-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Endoweave Disposable Grasper, 5mm x 43cm length, REF/Produ recall (Z-0100-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 33cm leng recall (Z-0101-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 43cm leng recall (Z-0102-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm length recall (Z-0103-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 43cm length recall (Z-0104-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Allis Disposable Dissector, 5mm x 33cm length, REF/Product recall (Z-0105-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Allis Disposable Dissector, 5mm x 43cm length, REF/Product recall (Z-0106-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 33cm lengt recall (Z-0107-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 43cm lengt recall (Z-0108-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 33cm length, REF/Pro recall (Z-0109-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 43cm length, REF/Pro recall (Z-0110-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Dissector, 5mm x 33cm le recall (Z-0111-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Dissector, 5mm x 43cm le recall (Z-0112-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Dissector, 5mm x 33cm leng recall (Z-0113-2007)Conmed Corporation2006-10-27
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Dissector, 5mm x 43cm leng recall (Z-0114-2007)Conmed Corporation2006-10-27