The following data is part of a premarket notification filed by Microsurgical Laboratories,inc.dba Wexler Surgical with the FDA for Wexler Endoscope Accessories.
| Device ID | K110121 |
| 510k Number | K110121 |
| Device Name: | WEXLER ENDOSCOPE ACCESSORIES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL 540 COLLEGE STREET Bellaire, TX 77401 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL 540 COLLEGE STREET Bellaire, TX 77401 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-18 |
| Decision Date | 2011-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M944NL8402130 | K110121 | 000 |
| M944NL8601130 | K110121 | 000 |
| M944NL8601150 | K110121 | 000 |
| M944NL8602130 | K110121 | 000 |
| M944NL8602150 | K110121 | 000 |
| M944NL8603150 | K110121 | 000 |
| M944NL860315H0 | K110121 | 000 |
| M944NL8604150 | K110121 | 000 |
| M944NL860415H0 | K110121 | 000 |
| M944NL8608150 | K110121 | 000 |
| M944NL8610150 | K110121 | 000 |
| M944NL8611150 | K110121 | 000 |
| M944NL8600150 | K110121 | 000 |
| M944NL8600130 | K110121 | 000 |
| M944NL8405150 | K110121 | 000 |
| M944NL8406150 | K110121 | 000 |
| M944NL8407150 | K110121 | 000 |
| M944NL8408150 | K110121 | 000 |
| M944NL8409150 | K110121 | 000 |
| M944NL8410150 | K110121 | 000 |
| M944NL8411150 | K110121 | 000 |
| M944NL8412150 | K110121 | 000 |
| M944NL8590130 | K110121 | 000 |
| M944NL8592130 | K110121 | 000 |
| M944NL8598150 | K110121 | 000 |
| M944NL8612150 | K110121 | 000 |
| M944NL8614150 | K110121 | 000 |
| M944NL8616150 | K110121 | 000 |
| M944SL862410 | K110121 | 000 |
| M944SL862510 | K110121 | 000 |
| M944SL862610 | K110121 | 000 |
| M944SL862810 | K110121 | 000 |
| M944SL86281FP0 | K110121 | 000 |
| M944SL863010 | K110121 | 000 |
| M944SL864010 | K110121 | 000 |
| M944SL864210 | K110121 | 000 |
| M944SL864310 | K110121 | 000 |
| M944SL864810 | K110121 | 000 |
| M944SL87201H0 | K110121 | 000 |
| M944SL86221H0 | K110121 | 000 |
| M944SL862210 | K110121 | 000 |
| M944FL8627120 | K110121 | 000 |
| M944SL86411H0 | K110121 | 000 |
| M944FL865010 | K110121 | 000 |
| M944FL865210 | K110121 | 000 |
| M944FL8447120 | K110121 | 000 |
| M944FL8616120 | K110121 | 000 |
| M944NL860115FP0 | K110121 | 000 |
| M944NL860215FP0 | K110121 | 000 |
| M944SL861810 | K110121 | 000 |
| M944SL862010 | K110121 | 000 |
| M944SL862110 | K110121 | 000 |
| M944FL8614120 | K110121 | 000 |