Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgical Technologies, Inc. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
400 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941992 | CYSTOSCOPE | Surgical Technologies, Inc. | 1995-11-30 | 584 | 0 |
| K942029 | ARTHROSCOPE | Surgical Technologies, Inc. | 1995-11-08 | 561 | 0 |
| K946136 | INFINITECH LIGHTED INFUSION CANNULA | Surgical Technologies, Inc. | 1995-10-02 | 290 | 0 |
| K952566 | OSCILFLATOR | Surgical Technologies, Inc. | 1995-08-31 | 90 | 0 |
| K951918 | SURGICAL TECHNOLOGIES, INC. SYRINGE | Surgical Technologies, Inc. | 1995-07-20 | 87 | 0 |
| K950683 | ARTHROGRAM TRAY | Surgical Technologies, Inc. | 1995-05-06 | 81 | 0 |
| K946135 | INFINITECH ASPIRATING LASER PROBE | Surgical Technologies, Inc. | 1995-04-18 | 123 | 0 |
| K946181 | INFINITECH SOFT TIP FLUTE NEEDLE | Surgical Technologies, Inc. | 1995-03-14 | 84 | 0 |
| K942030 | BIOPSY SCISSORS | Surgical Technologies, Inc. | 1994-06-27 | 62 | 0 |
| K942482 | PRESSURE MONITORING EXTENSION | Surgical Technologies, Inc. | 1994-06-14 | 20 | 0 |
| K941161 | FLEXIBLE GRASPING FORCEPS | Surgical Technologies, Inc. | 1994-05-04 | 54 | 0 |
| K941158 | FLEXIBLE BIOPSY CUP FORCEPS | Surgical Technologies, Inc. | 1994-04-28 | 48 | 0 |
| K930123 | ASPIRATING ENDO OCULAR PROBE | Surgical Technologies, Inc. | 1994-02-16 | 400 | 0 |
| K930180 | BIOPSY CUP FORCEPS | Surgical Technologies, Inc. | 1994-02-03 | 385 | 0 |
| K933208 | BARE-FIBER ENDOILLUMINATOR | Surgical Technologies, Inc. | 1993-12-14 | 166 | 0 |
| K931954 | THORACOSCOPE/LAPAROSCOPE | Surgical Technologies, Inc. | 1993-11-02 | 196 | 0 |
| K930463 | LOCKING PIVOTAL THORACOPORT | Surgical Technologies, Inc. | 1993-09-07 | 222 | 0 |
| K930462 | ENDOSCOPIC UMBRELLA RETRACTOR | Surgical Technologies, Inc. | 1993-07-22 | 175 | 0 |
| K930464 | BLUNT DISSECTING SCISSORS | Surgical Technologies, Inc. | 1993-06-04 | 127 | 0 |
| K930465 | WIRE GUIDED OVAL DILATORS | Surgical Technologies, Inc. | 1993-05-21 | 113 | 0 |
| K930467 | BABCOCK FORCEPS, GRASPING FORCEPS, NEEDLE HOLDER | Surgical Technologies, Inc. | 1993-05-21 | 113 | 0 |
| K930466 | COMPRESSION CLAMP | Surgical Technologies, Inc. | 1993-05-21 | 113 | 0 |
| K921488 | ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION | Surgical Technologies, Inc. | 1992-05-07 | 38 | 0 |
| K914247 | ASPIRATING ENDO OCULAR PROBE | Surgical Technologies, Inc. | 1991-12-18 | 86 | 0 |
| K911699 | STI TISSUE MANIPULATOR | Surgical Technologies, Inc. | 1991-06-13 | 58 | 0 |
| K910973 | DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE | Surgical Technologies, Inc. | 1991-04-26 | 50 | 0 |
| K910245 | I/A HANDPIECE WITH REPLACEABLE TIPS | Surgical Technologies, Inc. | 1991-04-22 | 90 | 0 |
| K910036 | SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES | Surgical Technologies, Inc. | 1991-04-04 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda