HRQ — Hemostat Class I
FDA product code HRQ covers "Hemostat", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HRQ
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K920298 | falcon instruments | DISPOSABLE HEMOSTATS | August 11, 1992 |
| K895683 | applied medical technologies | BERNARD VESSEL APPROXIMATOR | October 24, 1989 |
| K890245 | kinetic medical products | SURGICAL HEMOSTATS | January 27, 1989 |
| K884196 | disposable sterile surgical instruments | SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) | November 8, 1988 |
| K881937 | far east intl. trading | SURGICAL INSTRUMENTS | June 15, 1988 |
| K861807 | medcomp technologies | MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) | May 23, 1986 |
| K844152 | i m | HEMSTATS | November 7, 1984 |
| K843593 | syntex | SURGIPRESS SURGICAL LOOP | October 24, 1984 |
| K841514 | scanlan intl | SCANLAN VASCU-STATT II APPROXIMATOR | June 5, 1984 |
| K834175 | imm enterprises | OP-CON SURG. INSTRUMENTS #11 | January 27, 1984 |
| K831797 | i m | HEMOSTATS | July 19, 1983 |
| K823694 | scanlan intl | VASCU-STATT APPROXIMATOR | January 7, 1983 |
| K822263 | kelleher | VARIOUS TYPES OF TONSILS HEMOSTATS | August 16, 1982 |
| K821887 | scanlan intl | SCANLAN SUTURE-STATT | July 28, 1982 |
| K821617 | medcare products | DISPOSABLE HEMOSTATS | June 21, 1982 |