510(k) K860102
- Device
- MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE
- Applicant
- ENDOTHERAPEUTICS
- 510(k) number
- K860102
- Product code
- FHP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-12
- Date received
- 1986-01-10
- Regulation
- 876.1500
- Classification name
- Needle, Pneumoperitoneum, Simple
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUSSELL THOMPSON
- Address
- 654 Bair Island Rd. Suite 209 Redwood City CA US 94063 94063
FDA Registration Numbers#
- 3010383847
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FHP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910855 | ENDOPATH VERESS NEEDLE | Symbiosis Corp. | 1991-04-18 |
Legacy Summary#
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FDA Review#
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