HIB · Speculum, Vaginal, Nonmetal
Obstetrics/Gynecology · 21 CFR 884.4530 · Class 2
Overview
| Product Code | HIB |
|---|---|
| Device Name | Speculum, Vaginal, Nonmetal |
| Regulation | 21 CFR 884.4530 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
Classification Rationale
(1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Special Controls
*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Cleared Devices (72)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252208 | JFord Speculum Sleeve | Ford Medtech, LLC | Mar 6, 2026 | SESE |
| K133857 | BRELLA-SPEC(TM) VAGINAL SPECULUM | Proa Medical, Inc. | Apr 28, 2014 | SESE |
| K132668 | IOB DISPOSABLE SPECULUM | Iob Medical, Inc. | Jan 17, 2014 | SESE |
| K130046 | CLEARSPEC SINGLE USE VAGINAL SPECULUM | Clearspec, LLC | Aug 6, 2013 | SESE |
| K120743 | SPECULUM, VAGINAL, NONMETAL | Welch Allyn, Inc. | Mar 23, 2012 | SESE |
| K110766 | KOLPLUX SYSTEM | Kolplast CI Ltda | Sep 15, 2011 | SESE |
| K092870 | NON-STERILE DISPOSABLE VAGINAL SPECULUM | Kunshan Deyi Plastic Co., Ltd. | Feb 16, 2010 | SESE |
| K091937 | OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM | Obp Corporation | Sep 9, 2009 | SESE |
| K072942 | MEDLINE DISPOSABLE VAGINAL SPECULUM | Medline Industries, Inc. | Feb 8, 2008 | SESE |
| K072762 | DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM | Depalt, Inc. | Jan 22, 2008 | SESE |
| K070964 | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM | Welch Allyn, Inc. | May 18, 2007 | SESE |
| K061339 | HIERSPEC SPECULUM | Medical Products Div. | Sep 19, 2006 | SESE |
| K060129 | IGS VAGINAL SPECULUM | Innovative Gynecological Solutions, LLC | May 4, 2006 | SESE |
| K052420 | G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM | Gynova, LLC | Apr 6, 2006 | SESE |
| K052192 | FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I | Femspec LLC | Feb 2, 2006 | SESE |
| K052912 | YUSHENG DISPOSABLE VAGINAL SPECULUM | Zhejiang Yusheng Medical Instrument Co. , Ltd. | Dec 15, 2005 | SESE |
| K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE | Dynarex Corp. | Nov 9, 2005 | SESE |
| K050887 | GONGDONG DISPOSABLE VAGINAL SPECULUM | Zhejiang Gongdong Medical Plastic Factory | Jul 11, 2005 | SESE |
| K041757 | FEMSPEC DISPOSABLE VAGINAL SPECULUM | Femspec LLC | Dec 23, 2004 | SESE |
| K042950 | VAG O SPECULUM, MODELS VS1, VM1, VL1 | Panatrex, Inc. | Nov 30, 2004 | SESE |
| K040817 | POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM | Advanced Urological Developments | Jun 22, 2004 | SESE |
| K030693 | KENTEX DISPOSABLE VAGINAL SPECULUM | Kentron Health Care, Inc. | Aug 27, 2003 | SESE |
| K030761 | KAISHOU VAGINAL SPECULUM | Jiangsu Kaishou Medical Apparatus Co., Ltd. | Jun 9, 2003 | SESE |
| K022948 | VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L | Medical Action Industries, Inc. | Nov 4, 2002 | SESE |
| K021849 | TAGG DISPOSABLE VAGINAL SPECULUM | Tagg Industries | Jul 16, 2002 | SESE |
| K021676 | CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL | Cypress Medical Products, Ltd. | Jul 12, 2002 | SESE |
| K021017 | LEESPEC DISPOSABLE VAGINAL SPECULUM | Itl Corporation Pty, Ltd. | Jun 19, 2002 | SESE |
| K020959 | GLO-SPEC I, II AND III | Sol Weiss MD, Inc. | Jun 19, 2002 | SESE |
| K020726 | DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE | Dukal Corp. | May 15, 2002 | SESE |
| K012535 | DRG DISPOSABLE VAGINAL SPECULUM | Doctor'S Research Group, Inc. | Mar 1, 2002 | SESE |
| K013835 | GLOBAL HEALTHCARE VAGINAL SPECULUM | Dynascend Consulting Int'L, LLC | Jan 17, 2002 | SESE |
| K013817 | GLO-SPEC | Sol Weiss MD, Inc. | Dec 21, 2001 | SESE |
| K012859 | NU-SPEC D | Sol Weiss MD, Inc. | Oct 26, 2001 | SESE |
| K002912 | VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 | Sterinc | Feb 21, 2001 | SESE |
| K003540 | (DISPOSABLE) VAGINAL SPECULUM | Feminica, Inc. | Feb 9, 2001 | SESE |
| K000444 | MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM | Prism Enterprises, Inc. | Apr 21, 2000 | SESE |
| K000414 | MEDISUL DISPOSABLE VAGINAL SPECULUM | Marketing Perspectives | Apr 4, 2000 | SESE |
| K992736 | WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM | Wallach Surgical Devices, Inc. | Sep 29, 1999 | SESE |
| K991963 | PATTON SPECULUM | Patton Medical Corp. | Sep 1, 1999 | SESE |
| K991827 | GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 | Ri Mos. S.R.L. | Jul 19, 1999 | SESE |
| K984211 | MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 | Medscand AB | Dec 23, 1998 | SESE |
| K983716 | VITALCARE DISPOSABLE VAGINAL SPECULUM | Vitalcare Group, Inc. | Dec 23, 1998 | SESE |
| K973853 | KOLPLAST VAGINAL SPECULUM | Kolplast Comercial E Industrial Ltda | Dec 19, 1997 | SESE |
| K974228 | HOSPITAL'S SPEC | Gps | Dec 12, 1997 | SESE |
| K971979 | PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS | Playtex Products, Inc. | Sep 26, 1997 | SESE |
| K925501 | NYLON COATED SPECULA | Zinnanti Surgical Instruments, Inc. | Jun 13, 1997 | SESE |
| K963377 | EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC | North Eos Industries, Inc. | Oct 4, 1996 | SESE |
| K951898 | VERSA-VU | CooperSurgical, Inc. | Dec 11, 1995 | SESE |
| K951528 | AMSINO DISPOSABLE VIGINAL SPECULUM | Amsino Intl., Inc. | May 11, 1995 | SESE |
| K941272 | KLEENSPEC | Welch Allyn, Inc. | Aug 2, 1994 | SESE |
| K930954 | THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV | Cabot Medical Corp. | Jun 30, 1994 | SESE |
| K922154 | INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION | Olsen Electrosurgical, Inc. | Apr 21, 1994 | SESE |
| K935636 | GRAVESPEC | Adept-Med Intl., Inc. | Mar 25, 1994 | SESE |
| K933521 | SPECULUM | Bioteque America, Inc. | Mar 7, 1994 | SESE |
| K926536 | DISPOSABLE PLASTIC VAGINAL SPECULA | Thomasville Medical Assoc. | Feb 25, 1994 | SESE |
| K920803 | HSG TRAY | Unimar, Inc. | Oct 19, 1992 | SEKD |
| K903080 | DISPOSABLE PLASTIC VAGINAL SPECULUM | Dawnex Industries, Inc. | Sep 19, 1990 | SESE |
| K903744 | PHYSICIAN'S CHOICE | Advance Medical Device, Inc. | Sep 12, 1990 | SESE |
| K894957 | DISPOSABLE PLASTIC VAGINAL SPECULA | Zinnanti Surgical Instruments, Inc. | Oct 12, 1989 | SESE |
| K894489 | GYNECOLOGIC EXAMINATION KIT | A & A Medical, Inc. | Oct 5, 1989 | SESE |
| K880588 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4 | C.I.S.A. Import Export C/O Larson and Taylor | Dec 20, 1988 | SESE |
| K880587 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 | C.I.S.A. Import Export C/O Larson and Taylor | Dec 20, 1988 | SESE |
| K880586 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2 | C.I.S.A. Import Export C/O Larson and Taylor | Dec 20, 1988 | SESE |
| K882605 | EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM | Buckman Co., Inc. | Sep 15, 1988 | SESE |
| K863275 | MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM | Martin Medical | Sep 2, 1986 | SESE |
| K863274 | MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM | Martin Medical | Sep 2, 1986 | SESE |
| K842014 | HOSPITAL'S-SPEC | Merex Co. | Aug 17, 1984 | SESE |
| K841909 | VAGINAL SPECULUM - DISPOSABLE | Galenica Enterprises, Inc. | Jul 31, 1984 | SESE |
| K841867 | KIDD VAGINAL SPECULUM | Paul H. Schneider Ent. | Jul 13, 1984 | SESE |
| K830725 | GENT-L-SPEC DISPOS. VAGINAL SPECULUM | Geneva Laboratories, Inc. | Apr 27, 1983 | SESE |
| K822086 | DIA-SPEC | Exitec, Inc. | Nov 8, 1982 | SESE |
| K822084 | PRO-SPEC | Exitec, Inc. | Aug 19, 1982 | SESE |
Top Applicants
- Welch Allyn, Inc. — 3 clearances
- Sol Weiss MD, Inc. — 3 clearances
- C.I.S.A. Import Export C/O Larson and Taylor — 3 clearances
- Zinnanti Surgical Instruments, Inc. — 2 clearances
- Martin Medical — 2 clearances
