510(k) K910855
- Device
- ENDOPATH VERESS NEEDLE
- Applicant
- SYMBIOSIS CORP.
- 510(k) number
- K910855
- Product code
- FHP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-04-18
- Date received
- 1991-02-28
- 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
- KEVIN SMITH
- Address
- 5801 Miami Lakes Dr. Miami Lakes FL US 33014 33014
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 |
|---|---|---|---|
| K860102 | MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE | Endotherapeutics | 1986-02-12 |
Legacy Summary#
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FDA Review#
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