510(k) K991827
- Device
- GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043
- Applicant
- RI MOS. S.R.L.
- 510(k) number
- K991827
- Product code
- HIB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-07-19
- Date received
- 1999-05-28
- Regulation
- 884.4530
- Classification name
- Speculum, Vaginal, Nonmetal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ADENA NORA S RIEMER
- Address
- 100 Main St. Suite 120 Concord MA US 01742 01742
FDA Registration Numbers#
- 3012421607
- 9616088
- 1061124
- 3010155661
- 3045058049
- 3031184338
- 1315756
- 3012551896
- 3016904853
- 3030447506
- 3030626857
- 3011669217
- 3014637079
- 3015134755
- 3010419931
- 3014902417
- 3005739529
- 3006673317
- 3010830834
- 3015058854
- 2648727
- 3001124136
- 3003431869
- 3014579161
- 3018762668
- 3008902714
- 3007789561
- 3034669683
- 3013298431
- 3015895045
- 3016884191
- 2027062
- 3018779125
- 3016758972
- 2434982
- 3004488394
- 3038772401
- 3034629649
- 3030733800
- 3006410968
- 1417592
- 1319480
- 3009328501
- 3003528228
- 2435946
- 3014610488
- 3015276780
- 3000268902
- 3037918935
- 3006087789
- 3043226252
- 3038285060
- 3012292909
- 3015142721
- 3013517171
- 3013530901
- 3013557562
- 3033536319
- 9613910
- 3009104075
- 3011689956
- 1836161
- 8043235
- 1055236
- 1450908
- 3006787036
- 3014437893
- 3005273623
- 3016250458
- 3008496560
- 3004472854
- 3004941127
- 3009308092
- 3016195240
- 1216677
- 3012494290
- 3004530184
- 3000682787
- 3015173212
Source Documents#
Other 510(k) Records For Product Code HIB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252208 | JFord Speculum Sleeve™ | Ford Medtech, LLC | 2026-03-06 |
| K133857 | BRELLA-SPEC(TM) VAGINAL SPECULUM | Proa Medical, Inc. | 2014-04-28 |
| K132668 | IOB DISPOSABLE SPECULUM | Iob Medical, Inc. | 2014-01-17 |
| K130046 | CLEARSPEC SINGLE USE VAGINAL SPECULUM | Clearspec, LLC | 2013-08-06 |
| K120743 | SPECULUM, VAGINAL, NONMETAL | Welch Allyn, Inc. | 2012-03-23 |
| K110766 | KOLPLUX SYSTEM | Kolplast CI Ltda | 2011-09-15 |
| K092870 | NON-STERILE DISPOSABLE VAGINAL SPECULUM | Kunshan Deyi Plastic Co., Ltd. | 2010-02-16 |
| K091937 | OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM | Obp Corporation | 2009-09-09 |
| K072942 | MEDLINE DISPOSABLE VAGINAL SPECULUM | Medline Industries, Inc. | 2008-02-08 |
| K072762 | DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM | Depalt, Inc. | 2008-01-22 |
| K070964 | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM | Welch Allyn, Inc. | 2007-05-18 |
| K061339 | HIERSPEC SPECULUM | Medical Products Div. | 2006-09-19 |
| K060129 | IGS VAGINAL SPECULUM | Innovative Gynecological Solutions, LLC | 2006-05-04 |
| K052420 | G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM | Gynova, LLC | 2006-04-06 |
| K052192 | FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I | Femspec LLC | 2006-02-02 |
Legacy Summary#
summary
FDA Review#
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