DRG Disposable Vaginal Speculum
FDA 510(k) K012535 · Doctor'S Research Group, Inc.
510(k) numberK012535
Submission
- Device name
- DRG Disposable Vaginal Speculum
- Applicant
- Doctor'S Research Group, Inc.
Wolcott, CT, US - Received
- August 7, 2001
- Decision date
- March 1, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIB – Speculum, Vaginal, Nonmetal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252208 | JFord Speculum SleeveHIB · Traditional | Ford Medtech, LLC | 03/06/2026SE |
| K133857 | Brella-Spec(Tm) Vaginal SpeculumHIB · Traditional | Proa Medical, Inc. | 04/28/2014SE |
| K132668 | Iob Disposable SpeculumHIB · Traditional | Iob Medical, Inc. | 01/17/2014SE |
| K130046 | Clearspec Single Use Vaginal SpeculumHIB · Traditional | Clearspec, LLC | 08/06/2013SE |
| K120743 | Speculum, Vaginal, NonmetalHIB · Special | Welch Allyn, Inc. | 03/23/2012SE |
| K110766 | Kolplux SystemHIB · Traditional | Kolplast CI Ltda | 09/15/2011SE |
| K092870 | Non-Sterile Disposable Vaginal SpeculumHIB · Traditional | Kunshan Deyi Plastic Co., Ltd. | 02/16/2010SE |
| K091937 | Office-Spec Disposable Side-Opening SpeculumHIB · Traditional | Obp Corporation | 09/09/2009SE |
| K072942 | Medline Disposable Vaginal SpeculumHIB · Traditional | Medline Industries, Inc. | 02/08/2008SE |
| K072762 | Depalt Vaginal Specuim and Depalt Lighting SystemHIB · Traditional | Depalt, Inc. | 01/22/2008SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K051487 | DRG Laryngeal Augmentation Implant DeviceKHJ · Traditional | 12/22/2005SE |
| K041018 | DRG SoftreleaseHHT · Traditional | 10/18/2004SE |
| K012003 | DRG Reaction Chamber/Safety TipHEI · Traditional | 02/12/2002SE |
| K011736 | DRG QuickmixGXP · Traditional | 01/30/2002SE |
| K013786 | DRG Orthohex SS Bone ScrewHWC · Traditional | 12/17/2001SE |
| K002047 | DRG Puretone Stethoscope with DRG Antimicrobial, Stethoscope Diaphragm, Model…DQD · Traditional | 11/22/2000SE |
| K991714 | DRG Conventional Electronic Digital Stethoscope, Model Echop 200-00DQD · Traditional | 12/10/1999SE |
| K990212 | Lockjaw 15 Minute Intermaxillary Fixation System,Model LJ100-00DYX · Traditional | 09/14/1999SE |
| K990920 | DRG Titanium Bone PlateJEY · Traditional | 06/10/1999SE |
| K981881 | DRG Sherlock MF Bone Screw, Cocrmo Self-Tapping, Ti Alloy Self-Tapping/Self Drilling…DZL · Traditional | 12/02/1998SE |
Questions and answers
When was DRG Disposable Vaginal Speculum cleared by the FDA?
DRG Disposable Vaginal Speculum (K012535) received a 510(k) decision of Substantially Equivalent on March 1, 2002, 206 days after the submission was received.
What is the product code of K012535?
The FDA product code is HIB – Speculum, Vaginal, Nonmetal, a Class II (moderate risk) device regulated under 21 CFR 884.4530.