The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Bioshield-ercp Biopsy Valve, Model 00711138.
| Device ID | K070420 |
| 510k Number | K070420 |
| Device Name: | BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 |
| Classification | Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Michael Wolf |
| Correspondent | John Howlett BSI HEALTHCARE KITEMARK COURT, DAVY AVENUE KNOWLHILL Milton Keynes, GB Mk5 8pp |
| Product Code | ODD |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-02-20 |
| Decision Date | 2007-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765012489 | K070420 | 000 |
| 10724995183483 | K070420 | 000 |
| 10724995183506 | K070420 | 000 |
| 10724995183513 | K070420 | 000 |
| 10724995183520 | K070420 | 000 |
| 10724995183551 | K070420 | 000 |
| 10724995183568 | K070420 | 000 |
| 10724995183575 | K070420 | 000 |
| 10724995183582 | K070420 | 000 |
| 10724995183599 | K070420 | 000 |
| 20724995183497 | K070420 | 000 |
| 20724995183534 | K070420 | 000 |
| 00724995183547 | K070420 | 000 |
| 10724995190764 | K070420 | 000 |