510(k) K910875
- Device
- ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE
- Applicant
- ETHICON, INC.
- 510(k) number
- K910875
- Product code
- FDP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-03-19
- Date received
- 1991-03-01
- Regulation
- 876.1500
- Classification name
- Apparatus, Pneumoperitoneum, Automatic
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN PAULSON
- Address
- Rte. 22 W. P.O. Box 151 Somerville NJ US 08876 08876
FDA Registration Numbers#
- 3014279513
- 3005075853
- 1317547
- 1527736
- 3015183635
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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