Manual surgical instruments; slender tapered 302 stainless steel rods with knurled proximal ends and distal hook/arc tips. Used by physicians in clinical or operating room settings to snare, grasp, hold, and manipulate cervical, fundus, and adjacent soft tissue. Devices are supplied non-sterile; require cleaning and steam autoclave sterilization before use. No electronic or automated components.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Material: 302 stainless steel. Form factor: Slender tapered rod, ~250mm length, 3mm-8mm tip diameter. Manual operation. Sterilization: Steam autoclave (270°F for 30 minutes). Complies with ISO materials standards and Quality Systems Regulations.
Indications for Use
Indicated for grasping and manipulating cervical and intravaginal soft tissue during gynecological procedures.
Regulatory Classification
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.
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.
Emmett Tenaculum Hooks, V. Mueller, The Surgical Armamentarium, 1973
Submission Summary (Full Text)
{0}------------------------------------------------
K980247
P193
| Summary of Safety and | |
|----------------------------------------|--|
| Effectiveness Information | |
| Premarket Notification, Section 510(k) | |
| Gynex Instruments | |
| GYNEX Corporation | |
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 MAR 17 1998Device Name: 1.
| Trade Name: | Gynex Iris Hook<br>Gynex Angle Hook<br>Gynex Emmett Tenaculum |
|-------------|---------------------------------------------------------------|
|-------------|---------------------------------------------------------------|
Common Name: Tissue hook, tenaculum
Classification Name: Tenaculum
- Establishment Name & Registration Number: 2.
GYNEX Corporation Name:
Number: 3032109
#### Classification: 3.
\$ 884.4530 Obstetric-gynecologic specialized manual instrument. (a) 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 (b) Classification. Class II (performance expose and illuminate the interior of the vagina. standards).
{1}------------------------------------------------
Device Class: Class II
Classification Panel: Ob/Gyn Devices Panel
Product Code: 85HDC
## 4. Preamendments Device:
1. Emmett Tenaculum Hooks, V. Mueller, The Surgical Armamentarium, 1973.
## 5. Equivalent Legally Marketed Device(s):
- 1. UterineTenaculum, K890379 Mfg. by Kenetic Medical Products, Inc.
- 2. Champion Cervical Hook, K891349 Mfg. by Simpson/Basye, Inc.
- 3. Zinnanti Atraumatic Tenacula, K890133 Mfg. by Zinnanti Surgical, Inc.
### 6. Device Description:
The Gynex Iris and Angle Hooks & Emmett Tenaculums are made of 302 instrument grade stainless steel. All are used in similar way, each being a hook-like device used to snare, grasp, hold and manipulate the cervix, fundus and adjacent soft tissue. The important difference between the styles is that the radius of the hook tip is much smaller in the "Iris" and "angle" hook types. The devices are slender tapered metal rods, knurled on the proximal end and formed into a fine arc (hook) on the distal or working end. The devices are used to snare, hold and manipulate cervical and intravaginal tissue. Overall length of the hook/tenaculums is approximately 250mm for each type. The diameter of the hook tips is approximately 3mm for the Iris/angle styles and 8mm for the Emmett tenaculum style hook.
### 7. Applicant Name & Address:
GYNEX Corporation 16700 NE 79th St., Suite 204 Redmond, WA 98052
### Company Contact: 8.
Mr. Steve Angelo, President GYNEX Corporation 16700 NE 79th St., Suite 204 Redmond, WA 98052 425.882.1179 * 425.895.0115 - fax
# 9. Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 1000 Burnett Av., Suite 450 Concord, CA 94520 510.356.2640 - 510.356.2654 - fax
{2}------------------------------------------------
K980247
P3073
| Comparison Table:<br>10. | | | |
|--------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----|
| FEATURE | Gynex Iris/Angle Hook & Emmett<br>Tenaculum | Emmett Tenaculum<br>UterineTenaculum, Champion<br>Cervical Hook & Zinnanti<br>Atraumatic Tenacula | SE? |
| Indications for Use(s): | Snare, grasp, hold & manipulate cervical<br>and intravaginal tissue | Snare, grasp, hold & manipulate<br>cervical and intravaginal tissue | YES |
| Design: | Slender tapered metal rod | Slender tapered metal rod | YES |
| Sterilization Method: | Steam Autoclave | Steam Autoclave | YES |
| Sizes: | 3mm & 8mm tip diameter | 3mm & 4mm tip diameter | YES |
| Material: | 302 Stainless steel | 302 Stainless Steel | YES |
| Country of Orgin: | Germany | USA - Germany | YES |
| Manufacturer: | Gynex Corporation | Simpson/Basye, Kenetic Medical<br>Products, Zinnanti Surgical | YES |
| Product Code: | 84HDC | 84HDC | YES |
| K - Number: | Pending | Preamendment - K890379,<br>K891349, K891033 respectively | YES |
#### Voluntary Standards: 11.
United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, GYNEX Corporation. Standard Operating Procedures (SOP), vendor certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality requlations.
### Storage, Packaging & Sterilization Information: 12.
The Gynex Iris/Angle Hooks & Emmett Tenaculums are supplied in "clean only" condition and must be cleaned and sterilized prior to each use.
All packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging may indicate the presence of unsafe product and it should not be used until carefully inspected. Any shipping damaged instruments should be returned promptly. Product for use in the operating room must be processed, opened, inspected, handled and placed into use following accepted operating room sterile technique.
Remove all labels and packaging materials before cleaning and sterilization. Wash the Gyzex Iris/Angle Hooks & Emmett Tenaculums thoroughly with hot water using a typical hospital grade surgical instrument detergent or soap. Ultrasonic cleaners may be employed. Cleaning, rinsing and sterilization must be performed in accordance with usual hospital practice before first or any subsequent use.
The recommended sterilization process for the instruments is steam autoclave sterilization. The recommended sterilization cycle is: saturated steam at 270° F for 30 minutes. This is the typical or usual steam sterilization cycle use for surgical instruments.
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Image /page/3/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle emblem.
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 1998
Gynex Corporation c/o Mr. David W. Schlerf Buckman Company, Inc. 1000 Burnett Avenue, Suite 450 Concord, CA 94520
Re: K980247
Gynex Iris Hook, Gynex Angle Hook, and Gynex Emmett Tenaculum Dated: January 23, 1998 Received: January 23, 1998 Regulatory Class: II 21 CFR 884.4530/Procode: 85 HDC
Dear Mr. Schlerf:
We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ K. 980247
Device Name(s):
- 1. GYNEX Tenaculum
- 2. GYNEX Iris Hook
- 3. GYNEX Angle Hook
Intended Use:
- 1. GYNEX Tenaculum Grasp/manipulate the cervix & soft tissue
- 2. GYNEX Iris Hook Grasp/manipulate cervical tissue
- 3. GYNEX Angle Hook Grasp/manipulate cervical tissue
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Roler R Ratling
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K980247 |
|---------------|---------|
|---------------|---------|
| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional format 1-2-96) |
GYNEX-TENAC.doc
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
