Product code HRQ
- Device name
- Hemostat
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- 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 |
|---|---|---|---|
| K920298 | DISPOSABLE HEMOSTATS | Falcon Instruments, Inc. | 1992-08-11 |
| K895683 | BERNARD VESSEL APPROXIMATOR | Applied Medical Technologies | 1989-10-24 |
| K890245 | SURGICAL HEMOSTATS | Kinetic Medical Products | 1989-01-27 |
| K884196 | SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) | Disposable Sterile Surgical Instruments, Inc. | 1988-11-08 |
| K881937 | SURGICAL INSTRUMENTS | Far East Intl. Trading Corp. | 1988-06-15 |
| K861807 | MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) | Medcomp Technologies, Inc. | 1986-05-23 |
| K844152 | HEMSTATS | I M, Inc. | 1984-11-07 |
| K843593 | SURGIPRESS SURGICAL LOOP | Syntex Corp. | 1984-10-24 |
| K841514 | SCANLAN VASCU-STATT II APPROXIMATOR | Scanlan Intl., Inc. | 1984-06-05 |
| K834175 | OP-CON SURG. INSTRUMENTS #11 | Imm Enterprises , Ltd. | 1984-01-27 |
| K831797 | HEMOSTATS | I M, Inc. | 1983-07-19 |
| K823694 | VASCU-STATT APPROXIMATOR | Scanlan Intl., Inc. | 1983-01-07 |
| K822263 | VARIOUS TYPES OF TONSILS HEMOSTATS | Kelleher Corp. | 1982-08-16 |
| K821887 | SCANLAN SUTURE-STATT | Scanlan Intl., Inc. | 1982-07-28 |
| K821617 | DISPOSABLE HEMOSTATS | Medcare Products | 1982-06-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810212931135 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212931142 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212931166 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212931173 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212931128 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810055259694 | Surgical Design | Surgical Design, Inc. | 2026-05-27 |
| 00810055259731 | Surgical Design | Surgical Design, Inc. | 2026-05-27 |
| 00810055259724 | Surgical Design | Surgical Design, Inc. | 2026-05-27 |
| 00810055259717 | Surgical Design | Surgical Design, Inc. | 2026-05-27 |
| 00810055259700 | Surgical Design | Surgical Design, Inc. | 2026-05-27 |
| 00810055259687 | Surgical Design | Surgical Design, Inc. | 2026-05-27 |
| 00810055250714 | Surgical Design | Surgical Design, Inc. | 2026-05-27 |
| 00810055250707 | Surgical Design | Surgical Design, Inc. | 2026-05-27 |
| 00810055250691 | Surgical Design | Surgical Design, Inc. | 2026-05-27 |
| 00810055250684 | Surgical Design | Surgical Design, Inc. | 2026-05-27 |
| 10193489456325 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| ESAM3800121 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM3839141 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM3827141 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM3826141 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM3815141 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM3815121 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM3805141 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM3805121 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM3800141 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
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| 10381780024972 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780025016 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780023838 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-22 |
| 10381780023845 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-22 |