The following data is part of a premarket notification filed by Tti Medical with the FDA for Accu-beam Laparoscopic System.
| Device ID | K910978 |
| 510k Number | K910978 |
| Device Name: | ACCU-BEAM LAPAROSCOPIC SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TTI MEDICAL 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Contact | Lowell Crow |
| Correspondent | Lowell Crow TTI MEDICAL 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-07 |
| Decision Date | 1991-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B17791010030 | K910978 | 000 |
| B17793010 | K910978 | 000 |
| B1779301010 | K910978 | 000 |
| B17793020 | K910978 | 000 |
| B1779302010 | K910978 | 000 |
| B17793030 | K910978 | 000 |
| B1779303010 | K910978 | 000 |
| B1779304L0 | K910978 | 000 |
| B1779305L0 | K910978 | 000 |
| B1779306L0 | K910978 | 000 |
| B17793070 | K910978 | 000 |
| B17793100 | K910978 | 000 |
| B1779310100 | K910978 | 000 |
| B177910590 | K910978 | 000 |
| B177910300 | K910978 | 000 |
| B1770250040500C20 | K910978 | 000 |
| B1770250040514C0 | K910978 | 000 |
| B1773601300 | K910978 | 000 |
| B1773601310 | K910978 | 000 |
| B1773601320 | K910978 | 000 |
| B1773601330 | K910978 | 000 |
| B1773601350 | K910978 | 000 |
| B1773601360 | K910978 | 000 |
| B1773601380 | K910978 | 000 |
| B1773601390 | K910978 | 000 |
| B1773601450 | K910978 | 000 |
| B1773601460 | K910978 | 000 |
| B1779313L0 | K910978 | 000 |
| B1779314L0 | K910978 | 000 |
| B1779440F0270 | K910978 | 000 |
| B1779450L0 | K910978 | 000 |
| B1779451L0 | K910978 | 000 |
| B1779451L00 | K910978 | 000 |
| B1779452L0 | K910978 | 000 |
| B1779453L0 | K910978 | 000 |
| B1779453L00 | K910978 | 000 |
| B1779453L20 | K910978 | 000 |
| B1779455L0 | K910978 | 000 |
| B1779455L00 | K910978 | 000 |
| B1779457L0 | K910978 | 000 |
| B1779458L0 | K910978 | 000 |
| B1779440F0250 | K910978 | 000 |
| B1779440F0 | K910978 | 000 |
| B1779315L0 | K910978 | 000 |
| B17793302 | K910978 | 000 |
| B17793312 | K910978 | 000 |
| B1779350010 | K910978 | 000 |
| B1779351010 | K910978 | 000 |
| B1779352010 | K910978 | 000 |
| B1779353010 | K910978 | 000 |
| B1779354010 | K910978 | 000 |
| B17793580 | K910978 | 000 |
| B17793600 | K910978 | 000 |
| B17793610 | K910978 | 000 |
| B17793620 | K910978 | 000 |
| B177953970 | K910978 | 000 |