Product code FXO
- Device name
- Suit, Surgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4040
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914615 | BTP(TM) CENTRALINE(TM) SUIT | Btp Industries, Inc. | 1992-05-05 |
| K891212 | APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE | Pro-Safe Professional Linens, Inc. | 1989-04-14 |
| K882282 | SUIT, SURGICAL | A Plus International, Inc. | 1988-06-23 |
| K865022 | SURGICAL GARMENTS | Ulti-Med Intl., Inc. | 1987-01-12 |
| K831207 | SPUNGUARD SCRUB SUIT | Kimberly-Clark Corp. | 1983-05-16 |
| K822483 | MULTIPLE SCRUB SUIT | Surgilite Intl., Inc. | 1982-09-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10097604599921 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2025-09-10 |
| 10850044799616 | SURGYCO | Surgyco LLC | 2023-02-16 |
| 10850044799685 | SURGYCO | Surgyco LLC | 2023-02-16 |
| 10850044799678 | SURGYCO | Surgyco LLC | 2023-02-16 |
| 10850044799661 | SURGYCO | Surgyco LLC | 2023-02-16 |
| 10850044799654 | SURGYCO | Surgyco LLC | 2023-02-16 |
| 10850044799647 | SURGYCO | Surgyco LLC | 2023-02-16 |
| 10850044799630 | SURGYCO | Surgyco LLC | 2023-02-16 |
| 10850044799623 | SURGYCO | Surgyco LLC | 2023-02-16 |
| 10850044799609 | SURGYCO | Surgyco LLC | 2023-02-16 |
| 10850044799593 | SURGYCO | Surgyco LLC | 2023-02-16 |
| 26974239590046 | HUANFU | Hubei Huanfu Plastic Products Co., Ltd. | 2022-12-31 |
| 10097604440124 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 10097604440629 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 10097604440520 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 10097604440421 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 10097604440322 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 10097604440223 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 40884389144627 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2022-04-06 |
| 40884389144610 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2022-04-06 |
| 50885380018938 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-28 |
| 50885380018921 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-28 |
| 50885380018914 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-28 |
| 50885380018907 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-28 |
| 50885380018891 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-28 |
| 50885380018600 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-28 |
| 50885380018594 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-28 |
| 50885380018587 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-28 |
| 50885380018570 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-28 |
| 50885380018563 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-10-28 |