Surgical Specialties Corp. Dba Angiotech: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Surgical Specialties Corp. Dba Angiotech” (first 2012, latest 2013), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 16 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 15 |
| 2013 | 4 | 18 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 3 | 3 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | 2 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 2 | 2 |
Review panels
Most recent Surgical Specialties Corp. Dba Angiotech 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133420 | TRANQUILL BARBED DEVICE | NEW | 2013-11-29 | 21 |
| K131224 | SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE | GAW | 2013-05-16 | 16 |
| K130078 | QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | GAW | 2013-02-28 | 45 |
| K123877 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | NEW | 2013-01-02 | 16 |
| K123836 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | GAM | 2012-12-21 | 8 |
| K123409 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | GAM | 2012-11-20 | 15 |
| K122898 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | GAM | 2012-10-22 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Surgical Specialties Corp. Dba Angiotech.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Surgical Laser Technologies, Inc. (51 510(k)s)
- Surgical Specialties Corp (33 510(k)s)
- Surgical Technologies, Inc. (28 510(k)s)
- Surgical Navigation Technologies, Inc. (27 510(k)s)
- Surgical Instrument Service and Savings, Inc. (23 510(k)s)
- Surgical Dynamics, Inc. (12 510(k)s)
- Surgical Technology Laboratories, Inc. (12 510(k)s)
- Surgical Appliance Industries, Inc. (9 510(k)s)
- Surgical Instruments Service and Savings, Inc. (8 510(k)s)
- Surgical Theater, Inc. (8 510(k)s)
- Surgical Information Sciences, Inc. (7 510(k)s)
- Surgical Innovations Plc (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgical Specialties Corp. Dba Angiotech?
FDA lists 7 510(k) clearances under the applicant name “Surgical Specialties Corp. Dba Angiotech” (first 2012, latest 2013), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Surgical Specialties Corp. Dba Angiotech?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgical Specialties Corp. Dba Angiotech is 16 days.
Which FDA product codes appear under Surgical Specialties Corp. Dba Angiotech?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 3); GAW (Suture, Nonabsorbable, Synthetic, Polypropylene, 2); NEW (Suture, Surgical, Absorbable, Polydioxanone, 2).
Next steps
- See all 7 Surgical Specialties Corp. Dba Angiotech clearances with predicates and recalls
- Run predicate analysis for product code GAM, Surgical Specialties Corp. Dba Angiotech's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.