Data / Medical devices / United States / Combe Incorporated
Combe Incorporated: FDA-registered device maker in White Plains, NY, United States, 11 510(k) clearances
Combe Incorporated is registered with the FDA (registration 2412672) in White Plains, NY, United States. It lists 3 device types. The FDA files 11 510(k) clearances under its listings, the newest dated July 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2412672
- Address
- 1101 Westchester Ave, White Plains, NY, United States, 10604
- Owner or operator
- COMBE INCORPORATED (2412672)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 20, 1992
- Registered through
- 2026
- Brand names listed
- SEA BOND DENTURE ADHESIVE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer | KXX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Lubricant, Vaginal, Patient | MMS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2022 | K221036 | Astroglide Warming | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| May 26, 2022 | K220355 | Astroglide Ultra Gentle Gel | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| May 6, 2022 | K220653 | Astroglide Glycerin & Paraben Free | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| March 3, 2022 | K213671 | Astroglide Sensual Strawberry Personal Lubricant | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| April 28, 2021 | K210242 | Astroglide X Silicone Personal Lubricant | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| October 13, 2020 | K200114 | Astroglide Organix Liquid | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| August 30, 2017 | K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| July 21, 2017 | K171855 | External Moisturizing Gel | NUC | Substantially Equivalent | Combe Incorporated | accessdata.fda.gov |
| February 10, 2017 | K163395 | Astroglide Diamond Silicone Gel Personal Lubricant | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| May 1, 2015 | K150615 | Vaginal Moisturizing Gel | NUC | Substantially Equivalent | Combe Incorporated | accessdata.fda.gov |
| March 9, 2001 | K003867 | EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Lubricant, Personal
- All makers of Lubricant, Vaginal, Patient
- All makers of Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
Updated July 1, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.