Surgical Dynamics, Inc.: FDA clearances and approvals
Surgical Dynamics, Inc. has 12 FDA 510(k) clearances (first 1989, latest 1996), across 5 product codes in 3 review panels. Median 510(k) review time: 136 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| HRX | Arthroscope | 7 | 7 |
| GET | Motor, Surgical Instrument, Pneumatic Powered | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Surgical Dynamics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960046 | SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE | HRX | 1996-04-02 | 91 |
| K942987 | NUCLEOTOME L KIT | GET | 1995-10-30 | 497 |
| K954193 | SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET | HRX | 1995-10-23 | 47 |
| K950495 | SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 | BTA | 1995-05-09 | 92 |
| K931109 | NUCLEOTOME E KIT | HRX | 1994-03-29 | 391 |
| K921950 | SURGICAL DYNAMICS DISCOGRAPHY SYSTEM | FMI | 1993-06-07 | 406 |
| K923525 | NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR | HRX | 1993-02-09 | 208 |
| K914282 | NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER | HRX | 1991-12-19 | 86 |
| K913145 | NUCLEOTOME TISSUE ASPIRATOR/CUTTER | HRX | 1991-12-19 | 156 |
| K902778 | SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER | HRX | 1990-10-30 | 127 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgical Dynamics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Surgical Dynamics, Inc. have?
Surgical Dynamics, Inc. has 12 FDA 510(k) clearances (first 1989, latest 1996), across 5 product codes in 3 review panels.
How long does FDA take to clear Surgical Dynamics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Surgical Dynamics, Inc.'s cleared 510(k)s is 136 days.
What devices does Surgical Dynamics, Inc. make?
Its most frequent FDA product codes are HRX (Arthroscope, 7); GET (Motor, Surgical Instrument, Pneumatic Powered, 2); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Has Surgical Dynamics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Surgical Dynamics, Inc. Related entities may recall under other names.
Next steps
- See all 12 Surgical Dynamics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Surgical Dynamics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.