Cook Ob/Gyn: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Cook Ob/Gyn” (first 1985, latest 2006), across 25 product codes in 3 review panels. Median 510(k) review time under this name: 87 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 | 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 5 | 5 |
| MQF | Catheter, Assisted Reproduction | 5 | 5 |
| MQL | Media, Reproductive | 4 | 4 |
| HDR | Cap, Cervical | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| HFE | Brush, Endometrial | 2 | 2 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 2 | 2 |
| MFD | Cannula, Intrauterine Insemination | 2 | 2 |
| MQG | Accessory, Assisted Reproduction | 2 | 2 |
| EZN | Dilator, Catheter, Ureteral | 1 | 1 |
Plus 15 more product codes.
Review panels
Most recent Cook Ob/Gyn 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062438 | BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 | KNA | 2006-10-27 | 67 |
| K030441 | SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT | MQL | 2003-08-29 | 199 |
| K023850 | SYDNEY IVF EMBRYO BIOPSY MEDIUM | MQL | 2003-01-22 | 64 |
| K013597 | TAMPONADE UTERINE BALLOON CATHETER SET | KNA | 2002-04-17 | 168 |
| K002385 | COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM, | MQL | 2000-09-18 | 45 |
| K002383 | COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT | MQL | 2000-09-13 | 40 |
| K983595 | TRANSMYOMETRIAL EMBRYO TRANSFER SET | MQF | 1999-02-08 | 118 |
| K983596 | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING | MQH | 1999-02-05 | 115 |
| K983642 | COOK MINI-INCUBATOR | MQG | 1999-02-01 | 108 |
| K983593 | OVUM PICK-UP ASPIRATION NEEDLES | MQE | 1999-01-21 | 100 |
33 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-04-02.
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.
- Cook, Inc. (190 510(k)s)
- Cook Incorporated (174 510(k)s)
- Cook Urological, Inc. (104 510(k)s)
- Cook Pacemaker Corp. (34 510(k)s)
- Cook Ireland, Ltd. (33 510(k)s)
- Cook Biotech, Inc. (31 510(k)s)
- Cook Biotech Incorporated (16 510(k)s)
- Cook Vascular, Inc. (12 510(k)s)
- Cook Endoscopy (4 510(k)s)
- Cook Biotech Incorprated (4 510(k)s)
- Cook Advanced Technologies (1 510(k)s)
- Cook (Canada), Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cook Ob/Gyn?
FDA lists 43 510(k) clearances under the applicant name “Cook Ob/Gyn” (first 1985, latest 2006), across 25 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cook Ob/Gyn?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cook Ob/Gyn is 87 days.
Which FDA product codes appear under Cook Ob/Gyn?
The most frequent FDA product codes under this applicant name are HET (Laparoscope, Gynecologic (And Accessories), 5); MQF (Catheter, Assisted Reproduction, 5); MQL (Media, Reproductive, 4).
Next steps
- See all 43 Cook Ob/Gyn clearances with predicates and recalls
- Run predicate analysis for product code HET, Cook Ob/Gyn'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.