The following data is part of a premarket notification filed by Technology Delivery Systems, Inc. with the FDA for Maxiflex - Semi Flex Scope, 25 To 65 Cm.
| Device ID | K111480 |
| 510k Number | K111480 |
| Device Name: | MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | TECHNOLOGY DELIVERY SYSTEMS, INC. 1516 THALIA STREET New Orleans, LA 70130 |
| Contact | James Harvey Knauss |
| Correspondent | James Harvey Knauss TECHNOLOGY DELIVERY SYSTEMS, INC. 1516 THALIA STREET New Orleans, LA 70130 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-27 |
| Decision Date | 2012-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B324MFENDO65LUEA20 | K111480 | 000 |
| B324MFENDO55LUE0 | K111480 | 000 |
| B324MFENDO55LUA10 | K111480 | 000 |
| B324MFENDO55LU0 | K111480 | 000 |
| B324MFENDO55EA10 | K111480 | 000 |
| B324MFENDO55E0 | K111480 | 000 |
| B324MFENDO55A10 | K111480 | 000 |
| B324MFENDO550 | K111480 | 000 |
| B324MFENDO45LUEA10 | K111480 | 000 |
| B324MFENDO45LUE0 | K111480 | 000 |
| B324MFENDO45LUA10 | K111480 | 000 |
| B324MFENDO45LU0 | K111480 | 000 |
| B324MFENDO45EA10 | K111480 | 000 |
| B324MFENDO45E0 | K111480 | 000 |
| B324MFENDO45A10 | K111480 | 000 |
| B324MFENDO55LUEA10 | K111480 | 000 |
| B324MFENDO600 | K111480 | 000 |
| B324MFENDO60A10 | K111480 | 000 |
| B324MFENDO65LUEA10 | K111480 | 000 |
| B324MFENDO65LUE0 | K111480 | 000 |
| B324MFENDO65LUA10 | K111480 | 000 |
| B324MFENDO65LU0 | K111480 | 000 |
| B324MFENDO65EA10 | K111480 | 000 |
| B324MFENDO65E0 | K111480 | 000 |
| B324MFENDO65A10 | K111480 | 000 |
| B324MFENDO650 | K111480 | 000 |
| B324MFENDO60LUEA10 | K111480 | 000 |
| B324MFENDO60LUE0 | K111480 | 000 |
| B324MFENDO60LUA10 | K111480 | 000 |
| B324MFENDO60LU0 | K111480 | 000 |
| B324MFENDO60EA10 | K111480 | 000 |
| B324MFENDO60E0 | K111480 | 000 |
| B324MFENDO450 | K111480 | 000 |